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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
W69-1227857-0/9/1 04-Aug-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1230696-7/15/1 04-Aug-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1230696-7/2/1 04-Aug-2005 80FLK 1000553728 Ningbo Hualian Group Co Ltd China
 
AEK-6596815-4/7/1 02-Aug-2005 80FLL 1000352477 Wah Kong Precision China
 
AEK-6596815-4/7/2 02-Aug-2005 80FLL 1000352477 Wah Kong Precision China
 
AEK-6596815-4/7/3 02-Aug-2005 80FLL 1000352477 Wah Kong Precision China
 
110-2503803-8/3/1 26-Aug-2005 80FLL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
110-2503803-8/3/2 26-Aug-2005 80FLL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
110-2503803-8/3/4 26-Aug-2005 80FLL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
110-2503803-8/3/5 26-Aug-2005 80FLL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
110-2487416-9/3/1 26-Aug-2005 80FLL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
110-2487416-9/3/2 26-Aug-2005 80FLL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
144-5428001-9/1/1 17-Aug-2005 80FOR 3000150307 Medical Mart Supplies Canada
 
004-3968339-2/1/1 12-Aug-2005 80FRN 3003213434 B Braun Melsungen A.G. Germany
 
110-1975933-5/1/1 29-Aug-2005 80FSA 3002655016 B.h.m. Medical, Inc. Canada
 
110-1975933-5/2/1 29-Aug-2005 80FSA 3004113747 Linack Company United States
 
900-0044315-1/2/1 17-Aug-2005 80HFS 1000358444 Cannon Rubber Ltd United Kingdom
 
110-1573381-3/1/1 11-Aug-2005 80KXF 3004748768 Isohelix Ltd. United Kingdom
 
W69-1227857-0/7/1 04-Aug-2005 80KYZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
FR1-0011274-2/1/1 05-Aug-2005 80KZH 3003528643 Shanghai Kindly Enterprise Group Co. China
 
K51-0057462-0/1/1 10-Aug-2005 80LDQ 1000379039 Heine Optotechnik Gmbh & Co. KG Germany
 
K51-0057463-8/1/1 10-Aug-2005 80LDQ 3005242782 Dolphin Medical Pte Ltd Malaysia
 
EQ6-0004470-3/1/1 24-Aug-2005 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0004472-9/1/1 24-Aug-2005 80LDQ 5833 EPPENDORF AG Germany
 
240-0892827-7/1/1/D 26-Aug-2005 80LDQ 3005133210 Shanghai Lord International Trade Co., Ltd. China
 
349-8361441-2/1/1 27-Aug-2005 80LDQ 3005103557 Dragonheart Medical Devices Co China
 
349-8361441-2/1/2 27-Aug-2005 80LDQ 3005103557 Dragonheart Medical Devices Co China
 
349-8361441-2/1/3 27-Aug-2005 80LDQ 3005103557 Dragonheart Medical Devices Co China
 
322-2123571-9/1/1 27-Aug-2005 80LEY 3003755849 W & H DentalWerk Buermoos GMBH Austria
 
112-7736300-8/3/1 31-Aug-2005 80LYY 3002955419 Pt Medisafe Technologies Indonesia
 
112-7736300-8/4/1 31-Aug-2005 80LYY 3002955419 Pt Medisafe Technologies Indonesia
 
144-6255688-9/1/1 05-Aug-2005 80MDS 3003902721 HMD Biomedical Inc. Taiwan
 
FR1-0011284-1/1/1 12-Aug-2005 80MIA 3000247873 Nipro Corporation Japan
 
AQ1-3011536-5/1/1 17-Aug-2005 80MSH 3005148463 Carolyn WArbanton France
 
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