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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities.
Product...
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2
|
12/16/2014
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Snug Seat Inc
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Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L72,Exu-Dry Sheet 36"x72" Non...
|
2
|
03/12/2008
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Smith And Nephew, Inc. Wound Management Division
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Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73, Exu-Dry Sheet 36"x72" No...
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2
|
03/12/2008
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Smith And Nephew, Inc. Wound Management Division
|
Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L74, Exu-Dry Sheet 36"x72" Pe...
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2
|
03/12/2008
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Smith And Nephew, Inc. Wound Management Division
|
Silhouette Lift brochure
Silhouette Sutures are for use in midface suspension surgery to fixate t...
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2
|
07/23/2015
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Silhouette Lift, Inc.
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Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762...
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2
|
07/01/2015
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Sechrist Industries Inc
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Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
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2
|
11/07/2018
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Safe N Simple, LLC
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Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue numbe...
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2
|
11/07/2018
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Safe N Simple, LLC
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Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. ...
|
2
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10/30/2013
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S.A.E. AFIKIM
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Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), ...
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2
|
11/12/2014
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Roscoe Medical Inc
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Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001
Product ...
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2
|
05/09/2018
|
Roche Diabetes Care, Inc.
|
Respironics Trilogy 100, 200, and 202 Ventilators
The Respironics Trilogy systems provides contin...
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1
|
07/23/2012
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Respironics, Inc.
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Trilogy 100, 200 and 202 Ventilators
The device is intended to be used in home, institution/hospi...
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1
|
01/11/2012
|
Respironics, Inc.
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Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215
Pr...
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2
|
04/27/2017
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Remel Inc
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Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per c...
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2
|
06/10/2015
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Remel Inc
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Wombat Living, Size 3,
Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 9351...
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2
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05/11/2019
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R82 A/S
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BC Hammock Mesh Sling (Medium), product number, 537005.
Product Usage: Usage:
The fabric sling...
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2
|
06/19/2013
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Prism Medical Services USA
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BC Hammock Mesh Sling (Large), product number, 537030.
Product Usage:
The fabric sling is used f...
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2
|
06/19/2013
|
Prism Medical Services USA
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BC Hammock Mesh Sling (Small), product number, 537010.
Product Usage:
The fabric sling is used ...
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2
|
06/19/2013
|
Prism Medical Services USA
|
BC Hammock Mesh Sling (Junior), product number, 537005.
Product Usage:
The fabric sling is used...
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2
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06/19/2013
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Prism Medical Services USA
|
Victory 9 with Power Seat (SC609PS)
Motorized wheelchair with elevating seat.
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2
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07/03/2012
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Pride Mobility Products Corp
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Victory 10, 3 Wheel (SC610)
Mobility medical device
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2
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09/14/2011
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Pride Mobility Products Corp
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Victory 10, 4 Wheel (SC710)
Mobility medical device
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2
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09/14/2011
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Pride Mobility Products Corp
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Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, ...
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2
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08/27/2008
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Pride Mobility Products Corp
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Victory Motorized Vehicle, 3 wheel Model SC1600
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2
|
01/05/2005
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Pride Mobility Product Corp
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Victory Motorized Vehicle 4 wheels Model SC1700
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2
|
01/05/2005
|
Pride Mobility Product Corp
|
Trilogy Ventilators
The Respironics Trilogy 100 system provides continuous or intermittent ventilat...
|
1
|
03/06/2014
|
Phillips Respironics, Inc.
|
eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima
A disposable heel warmer for...
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2
|
04/04/2016
|
Philips Electronics North America Corporation
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evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim
A disposable heel warmer for use whe...
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2
|
04/04/2016
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Philips Electronics North America Corporation
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Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
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2
|
12/24/2015
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Philips Electronics North America Corporation
|
Permobil Chairman 2K powered wheelchair
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2
|
05/15/2003
|
Permobile Inc.
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Permobil Chairman 2K powered wheelchair, Model 1280
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2
|
03/21/2003
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Permobile Inc.
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Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e...
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2
|
09/15/2018
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Permobil, Ab
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Electric Wheelchair bases:
a) C300
b) C350
c) C400
d) C500
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2
|
10/03/2017
|
Permobil, Ab
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Electric Wheelchairs:
a) C300 CORPUS II
b) C350 CORPUS II
c) C400 CORPUS II
d) C400 CORPUS II LR...
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2
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10/03/2017
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Permobil, Ab
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Permolock C3, Docking system for Power wheelchair in vehicle.
Intended use: locking device
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2
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03/22/2012
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Permobil Inc
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NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM
MASS SPECTROMETRY KIT
Product Number: 3026-0030.
...
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2
|
01/16/2013
|
Perkinelmer
|
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U.
Th...
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2
|
01/16/2013
|
Perkinelmer
|
Fuze Manual Tilt Wheelchair.
Fuze T50, Fuze T20 and Fuze T50 Jr
|
2
|
09/24/2014
|
Pdg Product Design Group Inc
|
MediChoice Dual-Release Folding Walker with 5" wheel
|
2
|
11/20/2014
|
Owens & Minor Distribution, Inc.
|
The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Neg...
|
2
|
01/27/2012
|
Novomedicus Llc
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The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Sing...
|
2
|
01/27/2012
|
Novomedicus Llc
|
Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04
The Nemschoff Perinatal Bassinet products are...
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1
|
02/01/2012
|
Nemschoff Chairs, Inc.
|
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
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2
|
09/17/2014
|
Motion Concepts
|
Barrier Hip Sheet with Side Pockets
|
2
|
08/14/2003
|
Molnlycke Health Care Inc
|
Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo...
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2
|
08/19/2008
|
Medline Industries Inc
|
Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo...
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2
|
08/19/2008
|
Medline Industries Inc
|
Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan fo...
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2
|
08/19/2008
|
Medline Industries Inc
|
Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaoh...
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2
|
10/17/2006
|
Medline Industries Inc
|
Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kao...
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2
|
10/17/2006
|
Medline Industries Inc
|
Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaoh...
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3
|
09/23/2006
|
Medline Industries Inc
|
Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kao...
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3
|
09/23/2006
|
Medline Industries Inc
|
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ;
RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/C...
|
2
|
08/25/2018
|
Medical Components, Inc dba MedComp
|
EasyCAL HbA1c Calibrator; REF 10658
Kit is packaged in a paper box containing 4 vials of 0.25ml of ...
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2
|
03/28/2018
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Medica Corporation
|
Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-...
|
2
|
11/22/2011
|
Medi-Physics Inc. dba GE Healthcare
|
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in b...
|
2
|
04/27/2019
|
Matrix Surgical Holdings, LLC
|
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in b...
|
2
|
04/27/2019
|
Matrix Surgical Holdings, LLC
|
Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a whit...
|
3
|
06/22/2005
|
Manan Medical Products, Inc.
|
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
|
2
|
04/24/2015
|
Lumenis Limited
|
Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers;
Manufactured by RH US...
|
2
|
02/23/2006
|
Lumenis Inc.
|
Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured ...
|
2
|
02/16/2006
|
Lumenis Inc.
|
APhL® HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc...
|
2
|
08/17/2007
|
Louisville Apl Diagnostics Inc
|
APhL® HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, Inc., Dor...
|
2
|
08/17/2007
|
Louisville Apl Diagnostics Inc
|
APhL® HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Dor...
|
2
|
08/17/2007
|
Louisville Apl Diagnostics Inc
|
Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339.
The...
|
2
|
05/19/2011
|
Lockheed-Martin Aculight
|
LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional Model numb...
|
2
|
04/12/2010
|
Lockheed-Martin Aculight
|
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used ...
|
2
|
02/14/2013
|
Lockheed Martin Gyrocam Systems, Inc.
|
ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is...
|
2
|
09/08/2009
|
Linvatec Corp. dba ConMed Linvatec
|
Liko AB Uno Lifts, Powered (non-AC) Patient Lift:
Uno 100 EM/EE: S/N 7090001 through 7096200
Uno ...
|
2
|
01/27/2009
|
Liko North America Inc
|
Liko AB Uno Lifts, Powered (non-AC) Patient Lift:
Old Uno 102: S/N 20001 through 21300
New Uno 10...
|
2
|
01/27/2009
|
Liko North America Inc
|
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max ...
|
2
|
07/20/2012
|
Leica Microsystems, Inc.
|
Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component ...
|
2
|
03/21/2012
|
Leica Microsystems, Inc.
|
Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the co...
|
2
|
02/16/2012
|
Leica Microsystems, Inc.
|
Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-4...
|
2
|
06/24/2006
|
Leica Microsystems, Inc.
|
Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., ...
|
3
|
07/20/2004
|
Lang Dental Mfg Co, Inc.
|
Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt....
|
3
|
07/20/2004
|
Lang Dental Mfg Co, Inc.
|
Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the followin...
|
3
|
07/20/2004
|
Lang Dental Mfg Co, Inc.
|
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla...
|
2
|
05/17/2012
|
Kensey Nash Corp
|
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla...
|
2
|
05/17/2012
|
Kensey Nash Corp
|
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla...
|
2
|
05/17/2012
|
Kensey Nash Corp
|
Karma Flexx Wheelchair
Manual Wheelchair.
|
2
|
02/27/2016
|
Karman Healthcare Inc
|
LUCAS 2 Chest Compression System.
The device's Instruction for Use is labeled in part: "LUCAS 2...
|
3
|
03/16/2011
|
Jolife AB
|
Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole ...
|
2
|
03/13/2007
|
Inverness Medical Professional Diagnostics
|
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P
The intended use of a ...
|
2
|
12/03/2018
|
Invacare Corporation
|
Invacare® Pronto® Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare W...
|
2
|
08/10/2015
|
Invacare Corporation
|
FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 2...
|
2
|
02/20/2015
|
Invacare Corporation
|
TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 2...
|
2
|
02/20/2015
|
Invacare Corporation
|
Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs i...
|
2
|
02/20/2015
|
Invacare Corporation
|
MK5 NX Controller--Wheelchair controller
|
2
|
07/22/2014
|
Invacare Corporation
|
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Dist...
|
2
|
01/08/2014
|
Invacare Corporation
|
Invacare Power Wheelchair, one per box
To provide mobility to a person restricted to a sitting po...
|
2
|
09/23/2013
|
Invacare Corporation
|
Solara 3G Custom Manual Wheelchair
Product Usage: To provide mobility to a person restricted to...
|
2
|
02/04/2013
|
Invacare Corporation
|
TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, T...
|
2
|
06/29/2012
|
Invacare Corporation
|
TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By:...
|
2
|
03/12/2012
|
Invacare Corporation
|
Leo 3-Wheel Scooter and Leo Scooter, Distributed By:
Invacare Corporation, 1200 Taylor Street, Elyr...
|
2
|
01/17/2012
|
Invacare Corporation
|
Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels,...
|
2
|
09/27/2011
|
Invacare Corporation
|
Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-...
|
2
|
12/29/2009
|
Invacare Corporation
|
Kuschall K Junior Manual wheelchair
|
2
|
11/25/2009
|
Invacare Corporation
|
Invacare Storm TDX SP Power Wheelchair with Stability Lock,
Model numbers: TDXSP, TDXSP-CG, and TD...
|
2
|
01/27/2009
|
Invacare Corporation
|
Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS.
|
2
|
07/04/2007
|
Invacare Corporation
|