MULTIPLE COUNTRIES (PODS ONLY)

(79 K - - GM) Silicone, Liquid, Injectable

108 Forrest Street , Cottesloe, WA AUSTRALIA

Notes:All devices. DE. Seasonal Affective Disorder Devices. (SAD Devices)

22 Letchworth Centre Ave , Salter, FN AUSTRALIA

Notes:MEDEC BioResonance System

P.O. Box N4361 , Nassau, BAHAMAS

Notes:HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/1999. Note HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827- 6201.

P.O. Box CB12611 , Nassau, BAHAMAS

Notes:HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/1999. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

P.O. Box 362, Roadtown , Tortola, BRITISH VIRGIN ISLANDS

Notes:HIV 2 Blood Test Kit. (aka HIV Testing Kit) HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:HIV 2 Blood Test Kit. (aka HIV Testing Kit) HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

30 Peshtersko Shouse Blvd , Plovdiv, BULGARIA

Desc:AWT-5000 and AWT-6000; Shockwave devices
Notes:Class III; This firm recently received a Promotion and Advertising Warning Letter for these shockwave devices. FDA believes these devices are Class 3 and need a PMA. Please verify when products make entry.

Desc:AWT-5000 and AWT-6000; Shockwave devices
Notes:Class III; This firm recently received a Promotion and Advertising Warning Letter for these shockwave devices. FDA believes these devices are Class 3 and need a PMA. Please verify when products make entry.

43 Vanity Crest , Richmond Hill, ON CANADA

Notes:HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/2000. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/2000. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

1 Director Crt Ste 102 , Woodbridge, ON CANADA

Desc:T.E.N.S. Pro 900 Energy Point Stimulator
Notes:Class III

P.O. Box 879 , Knowlton, QC CANADA

Notes:12/15/1998 Angelcare sound & Breathing Frequency Monitor.

7035 Fir Tree Drive , Mississauga, ON CANADA

Notes:HIV 1 & 2 ELISA. 7/10/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:HIV 1 & 2 ELISA. 7/10/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

#5-1 Westside Drive , Etobicoke, ON CANADA

Notes:All devices. GPI = DE. Revitalite Beautifying Soft Light Laser

Notes:7/9/2004                         The canadian firm was issued a warning letter from CDRH on 3/25/2004; warning them to discontinue marketing these devices to the United States. There is currently no evidence that these devices are marketed in the US by the manufacturer. Districts should be aware that although he correct product code for this is 89NHN; the product has been mis-coded as 95L-22 (laser products/Laster product for non-medical use).

27 Passmore Ave Unit #1 , Scarborough, ON CANADA

Notes:Eye Mask or Eye Masque.

10900 Hamon St. , Montreal, QC CANADA

Notes:HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/2000. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

1 200 Britannia Rd E , Mississauga, On CANADA

Desc:Porcine Pericardial Patch
Notes:Class II

Desc:BioMitral Bio-Aortic Replacement Aortic and Mitral Valve
Notes:Class III

Desc:Injectable Bio-Pulmonic Pulmonic Valve
Notes:Class III

Desc:MitroFix Mitral Valve Restoration

1104-3760 Albert Street , Burnaby, BC CANADA

Notes:Bone Growth Stimulator 10/28/2005

Notes:Bone Growth Stimulator 10/28/2005

Notes:Bone Growth Stimulator. 10/28/2005

1124 S Service Rd W , Oakville, ON CANADA

Desc:Faceshield with one-way valve and filter
Notes:Class II

Desc:Faceshield with one-way valve and filter
Notes:Class II

9008-51 Avenue , Edmonton, Alberta, CANADA

Notes:6/29/2000 Oasis Cranial Electrotherapy Stimulator (CES)

18 Skagway Avenue , Scarborough, ON CANADA

Desc:Stimulator Electro-Acupuncture
Notes:Class III

5355 Parkwood Place , Richmond, BC CANADA

Desc:ECG Arrhythmia Simulator Model 10A and 20A
Notes:Class II

Desc:ECG Arrhythmia Simulator Model 10A and 20A
Notes:Class II

176 Bullock Dr #13 , Markham, Ontario CANADA

Desc:Neck Comforter
Notes:Class I

Desc:Neck Comforter
Notes:Class I

R.R. 2, Viking , Burnt River, Ontario CANADA

Desc:Sonafon Sonic Acupuncture
Notes:Class III

5796 Ambler Dr , Mississauga, ON CANADA

Notes:All devices. DWI = DE. 5/6/1994

9390 PIE IX Blvd. , Montreal, QC CANADA

Notes:All medical devices. GPI = DE, DI, BI, SD. 2/9/2005. The firm is known to have shipped and/or marketed the following products in the US Rapid HIV Test Kit, Class III device, Rapid Syphilis Test Kit, Class III Device, One Step Casette Style Cocaine Test Kit, Class II device, One Step Cassette Style Marijuana THC Test Kit, Class II device, One Step Cassette Style Amphetamine Test Kit, Class II Device, Rapid Dangue Fever Test Kit Class III device, One Step Midstream style HCG Urine Home Pregnancy Test Kit, Class III device. If districts encounter shipments of any device from the above shipper/markerting firm, contact DIOP attn Sammi Hadden 301-827-9632

145 Traders Blvd. East , Unit 34 , Mississauga, Ontario CANADA

Desc:Pressurized manometric pumps
Notes:Class II

Desc:Motility Catheters
Notes:Class II

Desc:Motility Catheters
Notes:Class II

Desc:Pressurized manometric pumps
Notes:class II

240 Davis Road , Gabriola Island, British Columbia CANADA

Desc:Search N Stim Electronic Acupuncture
Notes:Class III

165 Matheson Blvd E Suite 8 , Mississauga, ON CANADA

Notes:All devices. DWI = DE. Wipeout Long Life Activated Dialehyde. 4/27/1993.

P O Box 3899 Station C , Hamilton, ON CANADA

Notes:All devices. DWI = DE. Seasonal Affective Disorder Lights (SAD Lights) 2/4/1992

460 Hampton Court , Dollards Des Ormeaux, PQ , Montreal, Quebec CANADA

Notes:Class III; 3/5/09

Notes:Class III; 3/5/09

#616, 10216-124 St , Edmonton, AB CANADA

Notes:11/9/1999. HIV 1/2 Blood Test Kit. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:11/9/1999. HIV 1/2 Blood Test Kit. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

1755 St. Regis 210 , Dollard des Ormeaux , Quebec, QC CANADA

Notes:LARS (Ligament Advanced Reinforcement System) 10/13/1995

435 St. Valier , Granby, Quebec CANADA

Desc:John's Only Pump Enlargement Pump
Notes:Class II

Desc:John's Only Pump Enlargement Pump
Notes:Class II

1271 Denison Street , Suite 49 50 , Markham, ON CANADA

Notes:Office for Medionics International, Inc. All devices. QC Transfer Sets 12/15/1992

114 Anderson Avenue , Markham, Ontario CANADA

Notes:All devices. DWI = DE. QC Transfer Sets 12/15/1992

3070 Brabant-Marineau St , Saint Laurent, Quebec CANADA

Notes:All devices. DWI = DE. Seasonal Affective Disorder Lights (SAD Lights) 2/3/1992.

5764 Av De Monkland , Montreal, Quebec CANADA

Desc:Vimax System
Notes:Class II

Desc:Andro Penis Extender
Notes:Class II

Desc:Andro Penis Extender

Desc:Vimax System
Notes:Class II

344 Townsend Ave , Burlington, ON CANADA

Notes:The manufacturers website                         and the user manual shipped with the product states the product

Notes:The manufacturers website                         and the user manual shipped with the product states the product

Notes:The manufacturers website                         and the user manual shipped with the product states the product

3280 Schmon Parkway , Thorold, ON CANADA

Notes:All devices. GPI = DE. Spinal Anethesia trays containing tetracaine hydrochloride for use in the pediatric population. (3/5/1993 Continuous Spinal Anethesia Trays non-pediatric) (7/30/1993 Epi-spinal Tray Re-Order #2002 Epi Spinal Mini Kit Reorder #2005)

601 Gordon Baker Rd , , Toronto, Ontario CANADA

Desc:Motion Relief Wrist Bands
Notes:class II

1365 Beaumont Ave. , PO Box 65511 , Montreal, Alberta CANADA

Desc:Any Penile Corrective Devices
Notes:Class III

Desc:Any Penile Corrective Devices
Notes:Class III

6855 De L'Epee Avefloor: 3 Unit: 302 , Montrealmontreal, QUEBEC CANADA

Desc:Any Penile Corrective Devices
Notes:Class III

Desc:Any Penile Corrective Devices
Notes:Class III

P.O. Box 16047 , 3017 Mountain Highway , North Vancouver, BC CANADA

Notes:10/26/1999. Discreet HIV Test. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

unknown , unknown, Ontario CANADA

P.O. Box 383 , Collingwood, ON CANADA

Notes:10/20/1999 Ground Zero; Ground System and method for organisms (Ground Zero Grounding Device)

74 Simcoe Road , Kettleby, Ontario, CANADA

Notes:Decorative Contact Lenses. 4/7/2006.

Notes:Decorative Contact Lenses. 4/7/2006.

Notes:Decorative Contact Lenses. 4/7/2006.

Notes:Decorative Contact Lenses. 4/7/2006.

Notes:Decorative Contact Lenses. 4/7/2006.

Notes:Decorative Contact Lenses. 4/7/2006.

Notes:Decorative Contact Lenses. 4/7/2006.

Notes:Decorative Contact Lenses. 4/7/2006.

Notes:Decorative Contact Lenses. 4/7/2006.

8855 Northbrook Court , Burnaby, BC CANADA

Notes:Contact lenses, all types. 2/9/1993

145 Anderson Ave. , Markham, CA-ON CANADA

Desc:Neck Comforter
Notes:Class I

Desc:Neck Comforter
Notes:Class I

176 Bullock Dr #113 , Markham, Ontario CANADA

Desc:Neck Comforter
Notes:Class I

Desc:Neck Comforter
Notes:Class I

1365 Beaumont Ave. , PO BOX 65511 , Montreal, Alberta CANADA

Desc:Any Penile Corrective Devices
Notes:Class III

Desc:Any Penile Corrective Devices
Notes:Class III

6855 De L'Epee Ave. , Montreal, QC CANADA

Notes:x4 Penile corrective device. 9/16/2008

Desc:Any Penile Corrective Devices
Notes:Class III

Notes:x4 Penile corrective device. 9/16/2008

Desc:Any Penile Corrective Devices
Notes:Class III

9253 Shaughnessy Street , Vancouver, BC CANADA

Desc:iDream 1260 Head Massager
Notes:CLASS; I/II

Desc:iDream 1260 Head Massager
Notes:CLASS; I/II

Desc:iDream 1260 Head Massager
Notes:CLASS; I/II

Desc:iDream 1260 Head Massager
Notes:CLASS; I/II

9253 Shaughnessy Street St , Vancouvervancouver, BRITISH COLUMBIA CANADA

Desc:iDream 1260 Head Massager
Notes:CLASS; I/II

Desc:iDream 1260 Head Massager
Notes:CLASS; I/II

Desc:iDream 1260 Head Massager
Notes:CLASS; I/II

Desc:iDream 1260 Head Massager
Notes:CLASS: I/II

G F 5th Bldg Metal , Guangzhou, CHINA

Desc:Nocturns Anti-Glare Glasses
Notes:class II

Desc:Nocturns Anti-Glare Glasses
Notes:class II

Desc:Nocturns Anti-Glare Glasses
Notes:class II

38 Xinmin 4 St , Guangzhou, CHINA

Desc:Nocturns Anti-Glare Glasses
Notes:class II

Desc:Nocturns Anti-Glare Glasses
Notes:Class II

Desc:Nocturns Anti-Glare Glasses
Notes:class II

Yangwu District, Dalangtown , Dongguan City, CHINA

Desc:LED Skin Conditioning Kit Compact Light Therapy
Notes:Class II

Desc:LED Skin Conditioning Kit Compact Light Therapy
Notes:Class II

Desc:LED Skin Conditioning Kit Compact Light Therapy
Notes:Class II

Desc:LED Skin Conditioning Kit Compact Light Therapy
Notes:Class II

Desc:SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound
Notes:Class II

5th Floor, No. 4 Plant, Kechuang Ctr , 289 Wengjiao Rd., Xinyang St., Haicang , Xiamen, Fujian, CHINA

Desc:Mutation Detection Kit
Notes:Class III

Desc:Mutation Detection Kit
Notes:class III

No. 539 Wangjiang West Road , Hefei, CHINA

Desc:Portable Smart Massage U Disc Tens Unit
Notes:Class II

XIANDAO BUILDING, JINYUAN ROAD 36 , DAXING ECONOMIC DEVELOPMENT ZONE , BEIJING, CHINA

Desc:4S Beauty System
Notes:Class II

Desc:4S Beauty System
Notes:Class II

Desc:4S Beauty System
Notes:Class II ;

Desc:4S Beauty System
Notes:Class II

Desc:4S Beauty System
Notes:Class II ;

Desc:4S Beauty System
Notes:Class II ;

Desc:4S Beauty System
Notes:Class II

Desc:4S Beauty System
Notes:Class II

Desc:4S Beauty System
Notes:Class II

138 Area B Industrial Zone 3 , Guangzhou, CHINA

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic)

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ;

2 Jinfu Road , Beijing, CHINA

Desc:US309F Slimming Machine
Notes:Class II/III

Desc:US309F Slimming Machine
Notes:Class II/III

Rm A905 Fangqun Gongyusouth 3rd Ring , Beijingbeijing, CHINA

Desc:GL029 RF Cavitation Equipment
Notes:Class; Unknown

Desc:GL029 RF Cavitation Equipment
Notes:Class; Unknown

Lang Jia Yuan 6 Jianwaidajie , Beijingshi, Beijingshi CHINA

Desc:Led Photorejuvenation Device
Notes:Class II

Desc:Led Photorejuvenation Device
Notes:class II

Desc:Led Photorejuvenation Device
Notes:class II

42 Yangrouhutong , Beijingshi, Beijing CHINA

Desc:Neck Comforter
Notes:Class I

Desc:Neck Comforter
Notes:Class I

East 3rd Floor, Building M7 , No.1 Jiuxianqiao East Rd, Chaoyang Dist. , Beijing, CHINA

Notes:All devices. GPI = DE. 10/7/2008. CDRH has indicated DWPE of said products requiring 510k approval only if its being imported by                                                                                    Beijing Toplaser Technology Co. Ltd and                         have no cleared or pending 510ks with CDRH.

7 Chuangxin Rd , Beijing, CHINA

Notes:HIV 1 & 2 Rapid Test Kit 2/25/2004. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:HIV 1 & 2 Rapid Test Kit. 2/25/2004. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

5/F Taohuaguan High-Tech , Innovation Park , Shenzhen, CHINA

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

Xin Chang Rd 168-08 , Chang Zhou, CHINA

Desc:Green Tea
Notes:China

Weishu Beigang , Changzhou, CHINA

Desc:Green Tea
Notes:china

unknown , unknown , Shenzhen, CHINA

Notes:11/30/1994 Universal Massage Apparatus

75157 Xiazhuang Road , Shenzhen, CHINA

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

16b Donghua Garden , Bao And, CHINA

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

5015 Shennan Road 19f Benyuan Bl , Shenzhen, CHINA

Desc:Ultra Power LED Light Device
Notes:class II

Desc:Pimple Remover
Notes:Class II

No 1016 Shennan Road (E) Futian District , Room 406 Block A Chunhuiyuan , Shenzhen City, CHINA

Desc:Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado)
Notes:class II

Desc:Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado)
Notes:class II

Desc:Electro-acupuncture Machine Unclassified/(Sub-Health Diagnosis Require PMA Therapy Device)

Desc:Iriscope (Iriscopio)
Notes:class II

Mange Zone, Dongguan City, Tiantoujiao , Qiaotou Town , Dongguan, CHINA

Desc:Color Ray Beauty Light Therapy Device
Notes:Class II

Desc:Color Ray Beauty Light Therapy Device
Notes:Class II

Desc:Color Ray Beauty Light Therapy Device
Notes:Class II

Unknown Street , Beijing Haidian District, Donghua CHINA

Desc:Multiple Electronic Acupunctoscope
Notes:Class III

Rm A 18/F Development Bldeast Huayuan , Foshan, CHINA

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Hutougang, Dachong Industrial Zone , Lishui Town, Nanhai Dist., , Foshan, Guangdong CHINA

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Bldg Guangdong Shop T4163b 4fl A , Tianjian, CHINA

Desc:Portable High Frequency Spot Remover; JX-006A Massager
Notes:class II/III

Desc:Portable High Frequency Spot Remover; JX-006A Massager
Notes:Class II/III

Desc:Portable High Frequency Spot Remover; JX-006A Massager
Notes:Class II/III

NO 1901 TONGFANGTONGXIN BUILDING , WENSAN RD , HANGZHOU, Zhejiang CHINA

Notes:6/5/2009 "Perfectha Derm" Hyaluronic Acid for cosmetic injection.

A303,XUEFU ROAD, ZHONGRUN BUILDING , NANSHAN DISTRICT, , Shenzhen, CHINA

Desc:Bodycomfort EMS Abs and Arms
Notes:Class II

Desc:Bodycomfort EMS Abs and Arms
Notes:class II

Desc:Bodycomfort EMS Abs and Arms
Notes:class II

ROOM 1019, HENGSHENG BUILDING B, HUANSHI , ZHONG ROAD NO. 25, YUEXIU DISTRICT , GUANGZHOU, CHINA

Desc:Facial Beauty Machine
Notes:class II

Desc:SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes:Class II

Desc:Facial Beauty Machine
Notes:class II

Desc:SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes:Class II

Desc:SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes:Class II

Desc:SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes:Class II

Desc:SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes:Class II

Desc:SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes:Class II

Desc:SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes:Class II

Desc:SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes:Class II

Desc:SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes:Class II

Desc:SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes:Class II

Desc:SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes:Class II

Desc:SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes:Class II

Desc:SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes:Class II

Desc:SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes:Class II

Desc:SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes:Class II

Desc:Facial Beauty Machine
Notes:Class II

Desc:Facial Beauty Machine
Notes:class II

Desc:SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes:Class II

Desc:SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes:Class II

Desc:SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes:Class II

Desc:SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes:Class II

Desc:SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes:Class II

One International Finance Centre,18th FL , 1 Harbour View Street, Central , Hong Kong, CHINA

Notes:Pulse Generator; Pacemaker. 4/14/2003

Jin Lai Mansion, No 799 San Yuan Li Dao , Guangdong, CHINA

Desc:Condoms
Notes:Class II

Desc:Condoms
Notes:Class II

No 2 Workshop Lianyuan Roadsecond Rd , Guangzhouguangzhou, CHINA

Desc:Massage Ultrasound Equipment
Notes:Class III

Desc:Massage Ultrasound Equipment
Notes:Class III

Desc:Therapeutic Skin Ultrasound Devices
Notes:Class III

Desc:Massage Ultrasound Equipment
Notes:Class III

Desc:Therapeutic Skin Ultrasound Devices
Notes:Class III

Floor 3 Tower A, Fengsheng Industry , Guangzhou, CHINA

Desc:Skin Scrubber Beauty Machine
Notes:class II

Desc:Skin Scrubber Beauty Machine
Notes:class II

Desc:Skin Scrubber Beauty Machine
Notes:Class II

Dasha Village Industrial Park , Huangqi Town, Nanhai District , Foshan City, Guandong CHINA

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

Notes:All device products; Class I, II, III

No 7. Shajingbei East Rd.Yongxing Tajhe, , Baijun District , Guangzhou, CHINA

Desc:Detoxification Food Spa

Jiefangxi Road 128 , Panyu , Guangzhou City, Guangdong CHINA

Desc:Derma Stamp Electric Pen
Notes:Class II

Desc:Derma Stamp Electric Pen
Notes:Class II

Desc:Derma Stamp Electric Pen
Notes:class II

1-3 F, G#, Haan Bian Industrial Zone , 128#, Dong Huan Road, Pan Yu District , Guangzhou, CHINA

Desc:Manual Therapeutic Massager

Desc:Manual Therapeutic Massager
Notes:Class III

N. 23, 1st Floor, Mid Building, , TianfengPlaza #133-141 Baiyn Avenue No , Guangzhou, CHINA

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

Notes:All Devices; Class II

1# No 1 Street Hanzhou Ecomic An , Hangzhou, CHINA

Desc:HIV test kit
Notes:class II

Shui Wei Tang, Along Celebrates Area , Lotus Pond Road # 167 , Nanchong, Sichuan CHINA

Notes:2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Nanchang, Gushu , Xi'Xiang Town, Bao'an District , Shenzhen, CHINA

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

Desc:Electric TENS massager
Notes:class II

No 52 Shijia Rdjunhe St Baiyum , Guamgzhou Cityguamgzhou City, CHINA

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ;

No 52 Shijia Rdjunhe St Baiyum , Guamgzhou Cityguamgzhou City, CHINA

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

Notes:Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ;

2709 West Tower 12069 Shenan Rd , Shenzhen, CHINA

Desc:Digital Therapy Machine Tens Unit
Notes:Class II

669 Changjiang West Road , Heifei, CHINA

Notes:4/20/2000 Health Builder

Notes:Hothouse FIR Health Builder 11/26/2001

Eastern Area of Chengjiang Town , Industrial Park , Jiangyin City, CHINA

Desc:Portable Electric Steam Sterilizer (Model SYL-280B)
Notes:Class II

5f No.2 Bldg Dalang Indl Zone , Shenzhen, CHINA

Desc:Crystal Fat Deflagration Equipment
Notes:Class II

Desc:E Light Intense Pulsed Light Beauty Equipment
Notes:Class II

Desc:E Light Intense Pulsed Light Beauty Equipment
Notes:Class II

Desc:Crystal Fat Deflagration Equipment
Notes:Class II

Rm No.804 Guanlida Buildingqianjin Rd , Shenzhenshenzhen, CHINA

Desc:Bt-Micro Dermabrasion Unit
Notes:Class II

Desc:Bt-Micro Dermabrasion Unit
Notes:class II

4633 Pusan Road , Shanghai, CHINA

Desc:All IVD Tests
Notes:11/14/2008;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

Desc:All IVD Tests
Notes:11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

Desc:All IVD Tests
Notes:11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

No 8 Building, North Rd Of School , Guangdong, CHINA

Desc:Personal Slimming Machine
Notes:Class III

205 Huanshi Zhong Rd , Yanzhoushi, Guangdong CHINA

Desc:Executive Ion Detox Machine (TENS Unit; Far Infrared Belt; and Ion Detox)
Notes:Class II

Room 1701, Pengdu Building , Nanguang Road 126, , Shenzhen, Guangdong, CHINA

Desc:Laser Lipolysis Device
Notes:class II

Desc:Laser Lipolysis Device
Notes:class II

Desc:Laser Lipolysis Device
Notes:Class II

Desc:Laser Lipolysis Device
Notes:class II

Desc:Laser Lipolysis Device
Notes:class II

YANBU TOWN NANHAI , NO. 5 LIAN GUI ROAD INDUSTRIAL DISTRICT , FOSHAN, CHINA

Desc:Hair Steamer
Notes:Class II

Desc:Beauty Instruments
Notes:Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

Desc:Beauty Instruments
Notes:Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

Desc:Beauty Instruments
Notes:Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

Desc:Beauty Instruments
Notes:Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

Desc:Beauty Instruments
Notes:Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

Desc:Beauty Instruments
Notes:Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

Desc:Facial Brush and Vacuum
Notes:Class II

Desc:Vaporizer
Notes:Class II

Desc:Beauty Instruments
Notes:Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

Desc:Cosmetic Vibrator
Notes:Class II

Desc:Massage Hammer
Notes:Class II

Desc:Beauty Instruments
Notes:Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

No.8 Gulin Industrial District , Yinzhouyinzhou, CHINA

Desc:Radio Frequency Skin Lifting device
Notes:Class II

Desc:Radio Frequency Skin Lifting device
Notes:Class II

Room 703 Bldg 7 Of Tong Tai Garden , Wenzhou Zhejiang, CHINA

Desc:Plastic Cupping Set Breast Enlargement Cup
Notes:Class II

Desc:Plastic Cupping Set Breast Enlargement Cup
Notes:class II

Desc:Plastic Cupping Set Breast Enlargement Cup
Notes:class II

Desc:Plastic Cupping Set Breast Enlargement Cup
Notes:class II

Blk B&C 10/F Lee Hang Ind Bldg 10 Cheung , Cheung Sha Won Hong Koncheung Sha Won Ho, CHINA

Desc:Impulse Ion
Notes:Class II

Desc:Impulse Ion
Notes:Class II

Desc:Impulse Ion
Notes:Class II

No 142 Dong Feng Xi Road , Guangzhou, CHINA

Desc:GS8.0 Cavitation Machine
Notes:Class II

Desc:GS8.0 Cavitation Machine
Notes:Class II

Desc:GRF-11 Monopolor Radio Frequency machine
Notes:Class II

Desc:GS8.0 Cavitation Machine
Notes:Class II

Desc:GRF-11 Monopolor Radio Frequency machine
Notes:Class II

JINSHAN INDUSTRIAL PARK , DONGYANY , ZHEJIANG, CHINA

Notes:7/9/2009 Body Massage Kits.

1776 LV LING ROAD , XIAMEN, CHINA

Desc:ReBuilder 300 System; ReBuilder 2407 Personal System
Notes:Class II

Desc:ReBuilder 300 System; ReBuilder 2407 Personal System
Notes:Class II

1776 LV LING ROAD , XIAMEN, CHINA

Desc:ReBuilder 300 System; ReBuilder 2407 Personal System
Notes:Class II

Desc:ReBuilder 300 System; ReBuilder 2407 Personal System
Notes:Class II

No23 Fenghuang 4 Rd , Jiulong Industrial Park , Guangzhou City, CHINA

Desc:Biolift Beauty Machine
Notes:Class II

Desc:Biolift Beauty Machine
Notes:class II

Desc:Biolift Beauty Machine
Notes:class II

3f Bldg A1 Fuqiao 6th Ind Park Fuyong , Shenzhen, CHINA

Desc:Magic Masseuse (Electronic Stimulation Massage unit)
Notes:Class II

3, BUILDING A, NO 388, YINDU ROAD, XUHUI , DISTRICT, SHANGHAI , SHANGHAI, CHINA

Desc:Intense Pulsed Light (IPL) Systems

Desc:Intense Pulsed Light (IPL) Systems

No.25, 1st Industry Zone, Fenghuang Road , Xikeng Village, Henggang Town, Longgang , Shenzhen, Guangdong CHINA

Desc:Breast Enhancer Massager
Notes:class II

Desc:Breast Enhancer Massager
Notes:Class II

Desc:Breast Enhancer Massager
Notes:class II

Suite 310 10th Bldg No 3599 Qi Xin Rd , Shanghai, CHINA

Desc:Ultrasonic Scaler (B5 Model)
Notes:Class II

16 Baoding Road , Box 42 , Qingdao, CHINA

Notes:Shipper for Guanzhou NuhNan Shandong Medicines and Health Products. Positive/Negative Integrated Computer Control Augmented Sequential External Counter-Pulsation Device.

No. 25, Lane 1150 Kang Shen Rd. , Kangqiao Town, Pudong , Shanghai, CHINA

Desc:All IVD Tests
Notes:11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

Desc:All IVD Tests
Notes:11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

Desc:All IVD Tests
Notes:11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

30 North Xinghua , Shenyang, CHINA

Desc:EKSV-10A Urinalysis Test Strips
Notes:class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:Class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:Class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:Class II

Desc:EKSV-10A Urinalysis Test Strips
Notes:Class II

No. 52 , North Huanghe Street , Shenyang, CHINA

Notes:7/20/2005. BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator.

Notes:7/20/2005. BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator.

Notes:7/20/2005. BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator.

Notes:7/20/2005. BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator.

5a Huating 3 Guangye Rd. , Shenzhen, FN CHINA

Notes:11/8/2007 Ultrasound Scanner

Notes:11/8/2007 Ultrasound Scanner

Notes:11/8/2007 Ultrasound Scanner

Notes:11/8/2007 Ultrasound Scanner

Notes:11/8/2007 Ultrasound Scanner

Notes:11/8/2007 Ultrasound Scanner

Notes:11/8/2007 Ultrasound Scanner

Rm. 2202, 22/F Jinshan Bldg. , No. 5033, Shennan East Rd , Shenzhen, Guangdong, CHINA

Desc:uCrown Pro Head
Notes:class II

Desc:iComfort Eye-Z Eye and Temple Massager
Notes:class II

Desc:uCrown Pro Head & Eye Massager
Notes:class II

Desc:iComfort Eye-Z Eye and Temple Massager
Notes:class II

Desc:uCrown Pro Head
Notes:Class II

Desc:iComfort Eye-Z Eye and Temple Massager
Notes:Class II

5f No5 Bldg Minxing Industrialpark , Shenzhenshenzhen, CHINA

Desc:Digital Therapy Machine Tens Unit
Notes:class II

Nanshan Road 1017lianhua International , Shenzhen, CHINA

Desc:Penis Enlarger and Penis Extender
Notes:Class II

Desc:Penis Enlarger and Penis Extender
Notes:class II

Rm 839 Fude Bldg Huaide Fuyong Town , Shenzhen, CHINA

Desc:Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado)
Notes:class II

Desc:Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado)
Notes:class II

Desc:Electro-acupuncture Machine Unclassified (Sub-Health Diagnosis Require PMA Therapy Device)

Desc:Iriscope (Iriscopio)
Notes:Class II

4th Bldg, 3rd Industrial Zone , Shajing Town Shenzhen, CHINA

Notes:Electronic Cigarettes and Components 7/9/2009

Notes:Electronic Cigarettes and Components 7/9/2009

Notes:Electronic Cigarettes and Components 7/9/2009

Notes:Electronic Cigarettes and Components 7/9/2009

Notes:Electronic Cigarettes and Components 7/9/2009

Notes:Electronic Cigarettes and Components 7/9/2009

6/F Dajia Bldg Dongchang Rd Luchu Dist , Shenzhen, CHINA

Desc:Breast Enhancer Massager
Notes:class II

Desc:Breast Enhancer Massager
Notes:class II

Desc:Breast Enhancer Massager
Notes:class II

LONGFENG ROAD , XINSHENG,LONGGANG , Shenzhen, Guangdong CHINA

Desc:Detox Ion Foot Cleanse
Notes:CLASS II

Desc:Detox Ion Foot Cleanse
Notes:CLASS II

Rm101, Unit 3, #38 Building, Rose Garden , #88 Huaian West Rd. , Shijiazhuang, CHINA

Desc:Synthetic Exam Gloves
Notes:class II

Desc:Synthetic Exam Gloves
Notes:class II

Desc:Synthetic Exam Gloves
Notes:class II

Desc:Synthetic Exam Gloves
Notes:class II

Desc:Synthetic Exam Gloves
Notes:class II

Desc:Synthetic Exam Gloves
Notes:class II

No 9 Bixi Road Daliang , Guangdong, CHINA

Desc:Intense Pulsed Light (IPL) System (Non-Laser)
Notes:Class II

Desc:Intense Pulsed Light (IPL) System (Non-Laser)
Notes:Class II

168 Baizhang Road , Ningbo, CHINA

Notes:Patient Examination Gloves 9/23/2005

Notes:Patient Examination Gloves 9/23/2005

Notes:Patient Examination Gloves 9/23/2005

Notes:Patient Examination Gloves 9/23/2005

3F No.77 Suhong Middle Road, SIP , Jiangsu, CHINA

Desc:Penis Ring Tor II Pleasure Object
Notes:Class II

Desc:Luna Beads Luna Mini
Notes:class II

Desc:Luna Beads Luna Mini
Notes:Class II

102 Xiatangxincun , 54 # Lujing Xilu Yuexiuqu , Guangzhou City, CHINA

Notes:2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Industry Development Area, , 107 Country Road, West, Shihling Town , Hua-Du City, Guangdong, Guangdong CHINA

Desc:Pinhole Glasses
Notes:Class II

Desc:Pinhole Sunglasses
Notes:Class II

Desc:Pinhole Glasses
Notes:Class II

Desc:Pinhole Sunglasses
Notes:Class II

454# Yuanfei Rd Kuiwen Distweifang , Wei Fangwei Fang, CHINA

Desc:Intense Pulsed Light System Face Skin Cleaner
Notes:Class II

2656 Tongyin Street, Gaoxin District , Weifang, CHINA

Desc:Massager
Notes:Class II

Desc:Ultrasound Beauty Machine
Notes:Class; II

Desc:Massager
Notes:class II

Desc:Massager
Notes:class II

Xiasong Industry Zone, Songqiao Town, , Wenzhou, CHINA

Desc:Massagers Models; OS-102A; 103A; 105A; 106A; & 107A ONLY
Notes:Class II

Unknown , Fujian, CHINA

Desc:Multifunctional Massager
Notes:Class III

N403 Weiye , Xiamen, CHINA

Desc:Electric massagers Mio and Ami and Je Joue Brandd Vibrators
Notes:Class II

Desc:Electric massagers Mio and Ami and Je Joue Brandd Vibrators
Notes:class II

Desc:Electric massagers Mio and Ami and Je Joue Brandd Vibrators
Notes:class II

Shenzhen Minzhi Jie Doa Minkang Rd , Shenzhenshenzhen, CHINA

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

(N3p)Yue Ao Pu Hua Technology Parkda , Shenzhenshenzhen, CHINA

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

43rd Building , Yiwu, CHINA

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

2f,Bldg C, Longjing 2nd , Shenzhenshenzhen, CHINA

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

TANBEI INDUSTRIAL ZONE , TANBEL YUANXING ROAD, DONGSHENG , ZHONGSHAN, CHINA

Desc:SL-50 Cluster Laser
Notes:Class II

Desc:SL-50 Cluster Laser
Notes:Class II

Desc:SL-50 Cluster Laser
Notes:Class II

Zmc Building, 101-2#, N. Zhongshan Rd, , Hangzhou, 310003, China , Hangzhou, CHINA

Desc:Portable Smart Massage U Disc Tens Unit
Notes:Class II

4th Fl. Zhida Industry Longping Rd , Longgang Shenzhenlonggang Shenzhen, CHINA

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Bai Shi Huan Huan Cheng , Zhongsha, Guangdong CHINA

Desc:Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand)
Notes:Class III

Desc:Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand)
Notes:Class III

Longjing Fang Industrial Estate , Chang Ming Shui, Wu Gui Shan , Zhong Shan, Guang Dong CHINA

Desc:Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand)
Notes:Class III

Desc:Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand)
Notes:Class III

Cra 78f No.0-33 Int. 15 Apto. 302 , Bogota, COLOMBIA

Desc:Body Shaper
Notes:"Lipo Illusion" Compression Garment; Class II

18 Polanka , Trebic, CZECH REPUBLIC

Desc:Medical Support Stockings
Notes:Class II

ARBESOVA 797/3 , ROKYCANY, CZECH REPUBLIC

Desc:Would Be Gone Wound Healing Gel
Notes:Class I

Srobarova 1869/14 , Praha 10, CZ-NOTA CZECH REPUBLIC

Desc:Would Be Gone Wound Healing Gel
Notes:Class I

Smilovskeho 1264/5 , Praha, CZECH REPUBLIC

Desc:Would Be Gone Wound Healing Gel
Notes:Class I

Jyllingehoej 2 , Jyllingejyllinge, DENMARK

Desc:Auri Kit; Clamp ear pinning kit
Notes:class II

Desc:Auri Kit; Clamp ear pinning kit
Notes:Class II

Baltorpbakken 13 , Ballerup, DENMARK

Notes:All devices. GPI = DE. 4/29/1994

Maglebjergvej 4 , Kgs Lyngby, DENMARK

Desc:Penile Extender
Notes:Class II

Desc:Penile Extender
Notes:Class II

Bostamose Oesterstraede 1a , Klampenborg, DENMARK

Notes:Jes-Extender (penis extending device)12/18/2006

Notes:Jes-Extender (penis Extending Device 12/18/2006

Jyllingehoej 2 , Jyllinge, DENMARK

Desc:Auri Kit; clamp ear pinning kit
Notes:class II

Desc:Auri Kit; clamp ear pinning kit
Notes:Class II

Varbola kula, Marjamaa vald , Raplamaa, ESTONIA

Desc:Sybaritic Inc. (Sybaritic) Hydration Station
Notes:Class II

Pulttitie 8 , Helsinki, FINLAND

Notes:Tetanus IgG EIA Kit

El Medico Chirurgical , 56 Avenue De La Republique , La Ferte Bernard, FRANCE

Notes:Sterile Surgical Gloves.

Rue Max Planck Bp 711 , Labege Cedex, FRANCE

Notes:Oxane; Purified Silicone Oil (Intraocular Fluid for Retinal Re-attachment) 5/31/2001

5 Rue de La Fontaine , Arc Surtille , Arc Sur Tille, FRANCE

Notes:LARS (Ligament Advanced Reinforcement System) 10/13/1995

25, Quai De La Gare - C.E. No. 19 , Paris Cedex, FRANCE

Notes:All devices. GPI = DE.

21 Rue Francis Combe , Cergy Pontoise, FRANCE

Notes:All devices. GPI = DE. 12/28/1994

55 Rue De L'Eglise , Remalard, FRANCE

Notes:All Scar Management Gel Productrs (Medigel Z) 11/27/1996.

256 Rue Vignes Dardelain , Marsannay La Cote, FRANCE

Notes:Ligastic Artificial Ligaments. 10/13/1995

4 rue Jacques Monod , Technopole Montesquieu , Martillace, FRANCE

Notes:8/26/2003 Outline Ultra A Bioresorbable Polycrylamide Filler for Soft Tissue.

#4 Rue Cozette , Amiens, FRANCE

Notes:Audiokinetron Device. 3/29/1994.

Parc d'affaires NOVEOS , 4, avenue Reaumur , Clamart, FRANCE

Notes:9/9/1992 Chorus RM cardia pacemaker model 7023. Chorus II cardia pacemaker model 6234

32, CHEMIN DE LA VIOLETTE , 31240 L'UNION, FRANCE

Notes:Presso Dan 207 Pressure therapy apparatus 8/02/01

56 Rue Des Batignolles , Paris, FRANCE

Notes:Electronic Ear; or any device labeled or marked for auditory training; auditory integration or behavioral improvement.

6, Place de la Republique-Dominicaine , Paris, FRANCE

Notes:Electronic Ear or any deviced labled or marked for auditory training; auditory integration; or behavioral improvement. 2/5/1997

Kurzeller Str. 18 , Schwanau, GERMANY

Notes:Ondamed System Regulation Biofeedback Device 4/29/2003

P.O. Box 102 , Tuttlingen, GERMANY

Notes:Ondamed System Regulation Biofeedback Device 4/29/2003

Otto Hahn Strasse 19 , Herrenberg-Kuppingen, GERMANY

Notes:Ondamned System Regulation (Biofeedback Device) 4/29/2003 Lack of 510(k) Approval.

Zeppelinstrasse 7 , Gilching, GERMANY

Desc:Brain Amps
Notes:Class II

Lindener Str 15 , LINDENER STRASSE 15 , Wolfenbuettel, Niedersachsen GERMANY

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Notes:All Devices;class I/II/III

Hamburger Str 120 , 44135 Dortmund , Dortmund, Nordrhein-westfalen GERMANY

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Desc:Pocket Darkroom Contact Lenses
Notes:Class II

Litzel Rimbach , Rimbach, Hessen GERMANY

Desc:Quantron Resonance System (Body Stimulator)
Notes:class II

Raffineriestr. 8 , Neustadt, GERMANY

Notes:Spinal Anethesia Tray; COSPAN Continuous Spinal Anesthesia Tray; COSPAN Pediatric Spinal Anesthesia Tray; Curity Pediatric Continuous Spinal Anesthesia Tray.

Schutzenstrabe 5-7 , Tuttlingen, GERMANY

Notes:All devices. Total Joint or Condylar protheses for the Temporomandibular joint (TMJ) 4/16/1993. US Distributer >>> Leibinger L.P. 14540 Beltwood Parkway East Dallas, Texas 75244 <<<

Jean-monnet-str 6d , Fohren, Rheinland-pfalz GERMANY

Desc:EROS Brand Cosmetic Gels personal lubricants
Notes:Class II

Kapuzinerweg 12 , Stuttgart, GERMANY

Notes:Aniridia Implant Devices (Modified Intraocular Lenses)2/9/2004

Desc:modified intracular lenses or capsular tension rings) 5/31/2001
Notes:Aniridia Implant (ie

unknown , Stuttgart, GERMANY

Notes:DE = Nostrafon SK2 Sound Wave Appliance. Medi-Pol (magnetic field therapy used as an accessory device with Nostrafon Unit).

Atrikastr 2 , Hohenkirchen Siegertsbrunn, GERMANY

Notes:3/5/2009 miniZAP Blood Zapper

Schaferweg 14 , Flensburg, GERMANY

Desc:Breast Pump
Notes:Class II

Ehrenbergstrasse 11 , Ilmenau, GERMANY

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Notes:Osmed Hydrogel Tissue Expander; Class II

Greisbacherstrasse 6 , Burgau, GERMANY

Notes:All devices. Manufacturers for Anti-Aging Solutions. Revitalite Beautfying Soft Light Laser.

unknown , unknown, GERMANY

Notes:Magnetic Devices No classification name, number or regulation citation. 2/29/1996

Muhlen Koppel 2 , Ascheberg Trentrade, GERMANY

Notes:Silicone Oil for Opthalmic Use (Sterile)

Planegger Str 9a , Muenchen, GERMANY

Notes:9/13/2006 Epi-No Delphine Trainer Plus

Landwehrstrasse 70A , Munchen, GERMANY

Notes:Synvisc Hylan Syringe Kits. (Product has European label which contains indications for use not yet approved in the United States) 6/20/2006.

Wankelstrasse 5 , Gronau, GERMANY

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Desc:Terror Eyes Fashion Lenses
Notes:Class II

Room E 11/F West, Aidi Buildingbinhe , Hong Konghong Kong, HONG KONG

Desc:Portable High Frequency Spot Remover; JX-006A Massager
Notes:Class II/III

Desc:Portable High Frequency Spot Remover; JX-006A Massager
Notes:Class II/III

Desc:Portable High Frequency Spot Remover; JX-006A Massager
Notes:Class II/III

Flat 6 G/F Topsail Plaza 11 , On Sum Street Siu Lek Yuen Shatin , Fotan, Shatin, HONG KONG

Desc:GS8.0 Cavitation Machine
Notes:class II

Desc:GS8.0 Cavitation Machine
Notes:Class II

Desc:GRF-11 Monopolor Radio Frequency Machine
Notes:class II

Desc:GS8.0 Cavitation Machine
Notes:class II

Desc:GRF-11 Monopolor Radio Frequency Machine
Notes:Class II

582-592 Nathan Road , Kowloon, HONG KONG

Desc:SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound
Notes:Class II

Carnarvon Pl 15fl-20 Carnarvon , Tsimshatsui Kowloon, FN HONG KONG

Desc:Bio-Synthesis Light activated facial rejuvenation system
Notes:Class II

Desc:Bio Hydroderm Hydrodermabrasion System
Notes:Class II

Desc:Bio Hydroderm Hydrodermabrasion System
Notes:Class II

Desc:Bio-Hydroderm V2 Microderm Abrasion units
Notes:Class II

Desc:Bio-Synthesis Light activated facial rejuvenation system
Notes:Class II

Desc:Bt-Micro Dermabrasion Unit
Notes:class II

Desc:Bt-Micro Dermabrasion Unit
Notes:class II

Unknown , Hong Kong, HONG KONG

Notes:The Shealy RelaxMate (aka RelaxEase) 8/27/1998

Unit 2504 Mei Wan St , Tsuen Wan, HONG KONG

Desc:Contact lenses
Notes:class II

Desc:Contact lenses
Notes:class II

Desc:Contact lenses
Notes:class II

Desc:Contact lenses
Notes:class II

Desc:Contact lenses
Notes:class II

Desc:Contact lenses
Notes:Class II

Desc:Contact lenses
Notes:class II

Desc:Contact lenses
Notes:class II

Desc:Contact lenses
Notes:class II

Unit 206 Blk B Hi Tech Ind Ctr491-501 , Tsuen Wantsuen Wan, HONG KONG

Desc:Contact Lenses
Notes:class II

Desc:Contact Lenses
Notes:class II

Desc:Contact Lenses
Notes:class II

Desc:Contact Lenses
Notes:class II

Desc:Contact Lenses
Notes:class II

Desc:Contact Lenses
Notes:Class II

Desc:Contact Lenses
Notes:class II

Desc:Contact Lenses
Notes:class II

Desc:Contact Lenses
Notes:class II

5/F., 227 Wai Yip Street , Kwun Tong, Kowloon HONG KONG

Notes:All devices. GPI = DE. Shealy Relaxmate Glasses. 5/6/1994.

33 Canton Road , TRW 1 Room 2103 , Kowloon, HONG KONG

Notes:WhisperXL mini-sound amplifier (behind the ear hearing aid) 12/21/1994

610 Nathan Road Rm 1318-19 Hollywood , Kowloon, HONG KONG

Desc:RF Rejuvenation Device
Notes:Class II

Desc:RF Rejuvenation Device
Notes:Class II

5825 Nathan Road , Flat/Rm 701 Sino Ctr 582-592 , Mongkok, HONG KONG

Notes:Hothouse FIR Health Builder 11/26/2001

Unit 206, Block B491-501 Castle Peak , Tsuen Wantsuen Wan, HONG KONG

Desc:Contact Lenses (circle lenses)
Notes:Class II

Desc:Contact Lenses (circle lenses)
Notes:Class II

Desc:Contact Lenses (circle lenses)
Notes:Class II

Desc:Contact Lenses (circle lenses)
Notes:Class II

Desc:Contact Lenses (circle lenses)
Notes:Class II

Desc:Contact Lenses (circle lenses)
Notes:Class II

Desc:Contact Lenses (circle lenses)
Notes:Class II

Desc:Contact Lenses (circle lenses)
Notes:Class II

Desc:Contact Lenses (circle lenses)
Notes:Class II

1/F, 23 Mei Wan Street , Tsuen Wan, N.T., HONG KONG

Notes:HIVSCAN 1 2 Kit (Human Immunodeficiency Virus HIV-1 & HIV02 Test Kit) 10/28/2005. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:HIVSCAN 1 2 Kit (Human Immunodeficiency Virus HIV-1 & HIV02 Test Kit) 10/28/2005. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

G/F Fat Lee Ind Bldg , Tai Road , Kowloon Bay, Kwun Tong HONG KONG

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:Class II

Desc:Facial Beauty Machine
Notes:Class II

Desc:Facial Beauty Machine
Notes:class II

G/F Fat Lee Ind Bldg Tai Road,Kowloon , Kwun Tongkwun Tong, HONG KONG

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Desc:Facial Beauty Machine
Notes:class II

Flat/Rm 16a 7/F Well Fund Ind Ctr68ta , Tsim Sha Tsuitsim Sha Tsui, HONG KONG

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Notes:All Devices products; Class I, II, III

Unit 2401a, 24/f., Park-in Comm. Ctr. , 56 Dundas St., , Mongkok, HONG KONG

Desc:Ion Cleanse Massager
Notes:class II

Desc:Ion Cleanse Massager
Notes:Class II

2f 30 Haiphong Rd , Kowloon, HONG KONG

Desc:NARL 517 MS (Beauty Equipment Massager)
Notes:Class III

Desc:NARL 517 MS (Beauty Equipment Massager)
Notes:Class III

Shop 62a Nd Floor Mirrador Mansion , Kowloon, HONG KONG

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

Notes:All device products; Class I/II/III

1 Science Museum Rd , East Kowloon, HONG KONG

Notes:Emjoi Body Fat Monitor AP-30 (Body Composition Analyzer) 8/26/2003. Lack of 510(k) Approval.

300-306 Lockhart Road , Flat B, 4/F, Kiu Fu Comm. Building , Chai Wan, HONG KONG

Notes:OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Notes:OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis- diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Room 1202 Tower 2 Harbour Centre8 Hok , Hong Kong, HONG KONG

Desc:Day Light Bright Light Therapy Systems
Notes:Class II

2 Xing Wei Rd , Fuyong, HONG KONG

Desc:Muscle Stimulator
Notes:Class II

Desc:Muscle Stimulator
Notes:CLASS -- II

Flat 102-3, 1/F, Tung Chai Building , 86-90 Wellington Street , Hong Kong, HONG KONG

Notes:cool Ring Teether (Ring; Teething; Fluid-Filled) 2/9/2006

71 75 Container Port Rd , ROOM 1004, 10/F JOIN IN HANG SING CENTRE , Kwai Chung, HONG KONG HONG KONG

Desc:SL-50 Cluster Laser
Notes:Class II

Desc:SL-50 Cluster Laser
Notes:Class II

Desc:SL-50 Cluster Laser
Notes:Class II

Kalvaria Ter. 2 , Budapest, HUNGARY

Notes:Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008.

Napsugar U. 21 , Csomad, HUNGARY

Notes:Pollogen Regan/Pollegen MJ 5/12/2009 Shipper for Pollegen Ltd.

20 Sbi Officers Colony, 1st St , Arumbakkam, INDIA

Desc:Intraocular Lens Guides; Intraocular Lenses
Notes:Class III

Desc:Intraocular Lens Guides; Intraocular Lenses
Notes:Class III

20 Sbi Officers Colony, 1st St , Arumbakkam, INDIA

Desc:Intraocular Lens Guides; Intraocular Lenses
Notes:class III

Desc:Intraocular Lens Guides; Intraocular Lenses
Notes:Class III

20 Sbi Officers Colony, 1st St , Arumbakkam, INDIA

Desc:Intraocular Lens Guides; Intraocular Lenses
Notes:Class III

Desc:Intraocular Lens Guides; Intraocular Lenses
Notes:Class III

20 Sbi Officers Colony First St , Arumbakkam , Chennai, INDIA

Desc:Intraocular Lens Guides; Intraocular Lenses
Notes:Class III

Notes:Intraocular Lens

Desc:Intraocular Lens Guides; Intraocular Lenses
Notes:Class III

Nh 45-A, Vadamangalam Village, , Villupuram Main Road , Pondicherry, INDIA

Notes:Appavisv PFS Hydroxypropyl Methyl Cellulose Opthalmic Solution USP 2% Labeled for Intracular Use 6/19/2006

A-33/A SECTOR-8 , Noida (U.P.), INDIA

Notes:Latex Condoms 7/6/1992

Notes:Latex Condoms 7/6/1992

Notes:Latex Condoms 7/6/1992

17 Industrial Est. , Palam Rd , Mumbai, INDIA

Notes:All devices DWI = DE. Freeman Universal Intraocular Lenses (IOL) Anterior Chamber Optional Posterior Chamber. Style Code IMD-AC-FA. 7/6/1992.

207 Sector 7a Fardabad 121001 , Haryana, INDIA

Notes:Condoms 3/15/2005

Notes:Condoms 3/15/2005

Notes:Condoms 3/15/2005

3, Sant Nagar East of Kailash , New Delhi, INDIA

Notes:Condoms 3/10/2005

Notes:Condoms 3/10/2005

Notes:Condoms 3/10/2005

23 Russell Street , Next to 1 J M D H Road Joka 743 512 , Calcutta, INDIA

Notes:Intraocular Lenses 4/10/1995.

Yagur St 2 , Haifa, ISRAEL

Desc:Tripollar POSE; Tripollar STOP
Notes:Class II

TAVOR BUILDING, POB 533 , YOKNEAM, HA ZAFON ISRAEL

Desc:Invasix BodyTite (aka Invasix RFAL
Notes:Class II

40 Hataasiya Street, , P.O. Box 292 , Yehud, ISRAEL

Desc:Radialspec
Notes:Class III

6 Kaufman St Gibor House , P.O. Box 50320 , Tel Aviv, ISRAEL

Notes:Pollogen Regan 5/12/2009

6 Kaufman Street , Gabor House, Po Box 50320 , Tel Aviv, ISRAEL

Desc:Tripollar POSE; Tripollar STOP
Notes:Class II

Shatner Center 3 , Jerusalem, ISRAEL

Notes:HIV I and II One Step Tests 7/9/1998. Several FDA districts have encountered shipments of unapproved test kits and labeled for "research use only" or "investigationa use only" and some of the kits were unlabeled. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. Investigation by FDA revealed that the unapprived HIV diagnostic test kits were intended for commercial distribution, and not for "research" or "investigation" uses as invoiced. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted, contact CBER Import/Export team at 301-827-6201.

84061 LOC. TERZERIE, Z.I. , OGLIASTRO C. TO (SA) , OGLIASTRO, ITALY

Desc:SkinBella Crystal-Free Microdermabrasion System
Notes:Class I; Firm has no 510K for the product

Via F. Angrisani 18A , Agropoli, SA ITALY

Notes:SkinMaster MicroDermabrasion Product 1/2/2002

Notes:SkinMaster MicroDermabrasion Product 1/2/2002

Via Canncelliera 10/A , 00040 Albano Laziale , Rome, ITALY

Desc:Physia Pain Relief Machine
Notes:class II

Via Pitagora 15 35030 , Rubano, ITALY

Notes:12/08/1992 Pacemaker (Phymos ADV/VDD-M)

V Oberdan 21 , Fonte Nuovafonte Nuova, ITALY

Notes:Class III (8/18/09)

Notes:Class III (8/18/09)

Via Nardi, 98 Romano d'Ezzelino , Vience, ITALY

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Str Com Cartigliana 143 B , Bassano Del Grappabassano Del Grappa, ITALY

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Notes:All medical devices class I/II/III

Via Mestri Del Lavoro 120 , Cislago, ITALY

Desc:Dr Brux mouth guards night guards

Desc:Dr Brux mouth guards night guards

Viale Gramsci, N.29 , Mirandola, MO ITALY

Notes:Mesotherapy Needles and Hypodermic Needles 10/19/2005

Notes:Mesotherapy Needles and Hypodermic Needles 10/19/2005

Notes:Mesotherapy Needles and Hypodermic Needles 10/19/2005

Via Emilio Zago 8 , Bologna, BO ITALY

Notes:12/11/2006 Endosseous Implants & Abutments

Notes:12/11/2006 Endosseous Implants & Abutments

Notes:12/11/2006 Endosseous Implants & Abutments

Via F. Negri 15 , (Surg Med Aesthetic Supplies) , Casale Monferrato, AL ITALY

Notes:Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999

Via Tarlazzi, 5 , 31014 Colle Umberto (TV) , Umberto, Umberto ITALY

Notes:Sttila Evoluzione Electrical Stimulation Device. 4/12/2001.

9-11,Showa-Cho , Higashiosaka-Osaka, Osaka JAPAN

Notes:Massagers; Muscle Stimulators 4/29/2003

Notes:Massagers; Muscle Stimulators 4/29/2003

Notes:Massagers; Muscle Stimulators 4/29/2003

Notes:Massagers; Muscle Stimulators 4/29/2003

Notes:Massagers; Muscle Stimulators 4/29/2003

150 Ko-Machi , Tokyo, JAPAN

Notes:Wrinkle Chapeau Condoms. 7/20/1993

5-5-21 Nihonbashi,Naniwa-Ku , Osaka, JAPAN

Notes:All devices. DE. "New Health Club" Low Frequency Therapeutic Apparatus Type C Model HC-32. 8/13/1993

2-16-16, Yushima, Bunkyo-Ku , Tokyo 113, JAPAN

Notes:Sterilizer; Autoclave 9/17/1998

Gamo Block, 10-1 Kawai , Gamo-cho, Gamo-Gun , Shiga-Ken, JAPAN

Notes:Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/2005

17 11 3 Ishimaru , Osaka, Mino Shi JAPAN

Notes:Infant Heel Warmers Infant Crib Warmers 12/27/1994

2 4 2 Azaminominami , Kanagawa, JAPAN

Desc:NARL 517 MS (Beauty Equipment Massager)
Notes:Class III

Desc:NARL 517 MS (Beauty Equipment Massager)
Notes:Class III

2-11-9 Kasuga , Shizuoka, Kasuga JAPAN

Notes:Germanium Pellets Bandages 5/20/1996 All devices. DE.