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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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Karma Flexx Wheelchair
Manual Wheelchair.
|
2
|
02/27/2016
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Karman Healthcare Inc
|
LUCAS 2 Chest Compression System.
The device's Instruction for Use is labeled in part: "LUCAS 2...
|
3
|
03/16/2011
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Jolife AB
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Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole ...
|
2
|
03/13/2007
|
Inverness Medical Professional Diagnostics
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Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A a...
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2
|
01/03/2022
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Invacare Corporation
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Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A...
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2
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01/03/2022
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Invacare Corporation
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Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY...
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2
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01/03/2022
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Invacare Corporation
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Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P
The intended use of a ...
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2
|
12/03/2018
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Invacare Corporation
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Invacare® Pronto® Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare W...
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2
|
08/10/2015
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Invacare Corporation
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Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs i...
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2
|
02/20/2015
|
Invacare Corporation
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FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 2...
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2
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02/20/2015
|
Invacare Corporation
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TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 2...
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2
|
02/20/2015
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Invacare Corporation
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MK5 NX Controller--Wheelchair controller
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2
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07/22/2014
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Invacare Corporation
|
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Dist...
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2
|
01/08/2014
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Invacare Corporation
|
Invacare Power Wheelchair, one per box
To provide mobility to a person restricted to a sitting po...
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2
|
09/23/2013
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Invacare Corporation
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Solara 3G Custom Manual Wheelchair
Product Usage: To provide mobility to a person restricted to...
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2
|
02/04/2013
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Invacare Corporation
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TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, T...
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2
|
06/29/2012
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Invacare Corporation
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TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By:...
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2
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03/12/2012
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Invacare Corporation
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Leo 3-Wheel Scooter and Leo Scooter, Distributed By:
Invacare Corporation, 1200 Taylor Street, Elyr...
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2
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01/17/2012
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Invacare Corporation
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Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels,...
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2
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09/27/2011
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Invacare Corporation
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Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-...
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2
|
12/29/2009
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Invacare Corporation
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Kuschall K Junior Manual wheelchair
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2
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11/25/2009
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Invacare Corporation
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Invacare Storm TDX SP Power Wheelchair with Stability Lock,
Model numbers: TDXSP, TDXSP-CG, and TD...
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2
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01/27/2009
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Invacare Corporation
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Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS.
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2
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07/04/2007
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Invacare Corporation
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Solara Spree XT (SPRXT) manual wheelchair.
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2
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09/20/2006
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Invacare Corporation
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Solara 2G manual wheelchair.
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2
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09/20/2006
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Invacare Corporation
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Solara Spree GT manual wheelchair.
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2
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09/20/2006
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Invacare Corporation
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Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite.
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2
|
09/06/2006
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Invacare Corporation
|
Pronto M51 Wheelchair, component- seat
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3
|
08/10/2006
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Invacare Corporation
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3G Storm Series Power Wheelchair with Power Tilt Option.
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2
|
12/23/2005
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Invacare Corporation
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Pronto Series Power Wheelchair, model M51.
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2
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06/17/2005
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Invacare Corporation
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Pronto Series Power Wheelchair, model M50.
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2
|
06/17/2005
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Invacare Corporation
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Pronto Series Power Wheelchair, model M61.
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2
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06/17/2005
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Invacare Corporation
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Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs.
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2
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03/26/2003
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Invacare Corp
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Invacare Lynx and Panther Scooters, motorized 3-wheeled vehicles.
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2
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02/25/2003
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Invacare Corp
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Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sea...
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2
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09/30/2016
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Integra LifeSciences Corp.
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Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sea...
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2
|
09/30/2016
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Integra LifeSciences Corp.
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Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is ...
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2
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03/19/2012
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Integra LifeSciences Corp.
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iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class...
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2
|
10/19/2004
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Independence Technology LLC
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iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Clas...
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2
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08/24/2004
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Independence Technology LLC
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Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital stretcher co...
|
3
|
09/16/2008
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Hill-Rom, Inc.
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NeatNick Sweeping Action Heel Lancet - Preemie-
Item Number: 1030083 (box of 100) and
Item Number...
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2
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06/09/2007
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Hawaii Medical LLC
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NeatNick Sweeping Action Heel Lancet -Full-Term-
Item Number: 1030085 (box of 100) and
Item Numbe...
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2
|
06/09/2007
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Hawaii Medical LLC
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kids...
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2
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01/25/2012
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Gunnell, Inc.
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Toug...
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2
|
01/25/2012
|
Gunnell, Inc.
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab RAM
...
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2
|
01/25/2012
|
Gunnell, Inc.
|
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric ...
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2
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01/25/2012
|
Gunnell, Inc.
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab MAC ...
|
2
|
01/25/2012
|
Gunnell, Inc.
|
Lumex® Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, ...
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2
|
05/05/2007
|
Graham Field Atlanta
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Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod...
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2
|
12/19/2007
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Freedom Designs Inc
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e-fix E19 power drive. The product is a wheelchair component/accessory.
|
2
|
05/06/2005
|
Frank Mobility Systems, Inc.
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e-fix E20 power drive. The product is a wheelchair component/accessory.
|
2
|
05/06/2005
|
Frank Mobility Systems, Inc.
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Poly-bags containing splint strap labeled with "Pediatric" sticker.
Each strap kit contains adjus...
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2
|
05/04/2016
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Ferno-Washington Inc
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Poly-bags containing the strap labeled with "Adult" sticker.
Each strap kit contains adjustable l...
|
2
|
05/04/2016
|
Ferno-Washington Inc
|
Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System
Product Usage:
Stretc...
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2
|
10/01/2015
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Ferno-Washington Inc
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Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospita...
|
2
|
08/25/2015
|
Ferno-Washington Inc
|
Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow affixed label ...
|
2
|
01/11/2012
|
Eyezone
|
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 ...
|
2
|
06/25/2015
|
Ethicon, Inc.
|
Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair.
Height...
|
2
|
07/25/2013
|
Etac Supply Center Ab
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Etac® Ono Walker, Etac® Avant Walker, and Etac® Salsa Walker.
These products are four-wheeled wa...
|
2
|
07/14/2012
|
Etac Supply Center Ab
|
ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users u...
|
2
|
08/25/2010
|
Essential Medical Supply, Inc.
|
Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1...
|
2
|
07/20/2009
|
Essential Medical Supply, Inc.
|
HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. P...
|
2
|
01/17/2007
|
Embeem Inc.
|
Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-...
|
3
|
10/20/2006
|
EM Innovations Inc
|
Rascal 600F and 600T scooters, unspecified power wheelchair.
|
2
|
05/24/2006
|
Electric Mobility Corp
|
The EKOS cart has the catalog number 700-60101.
The EKOS cart is a custom infusion stand/cart use...
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2
|
09/27/2016
|
EKOS Corporation
|
Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motor...
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2
|
10/19/2006
|
Eagle Parts and Products
|
Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
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2
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10/19/2006
|
Eagle Parts and Products
|
100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corpo...
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2
|
07/20/2004
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Dynarex Corporation
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BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01
Product Usage - May provide a ster...
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2
|
12/12/2017
|
Dukal Corp.
|
Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI
Product Code: 0010211
...
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2
|
05/04/2010
|
Davol, Inc., Sub. C. R. Bard, Inc.
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Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Co...
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2
|
03/22/2005
|
Cypress Medical Products, Ltd.
|
Manual Mechanical Wheelchair, 16'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Co...
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2
|
03/22/2005
|
Cypress Medical Products, Ltd.
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Manual Mechanical Wheelchair, 24'' seat, , maximum patient weight: 450 lbs.; Marketed by McKesson Co...
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2
|
03/22/2005
|
Cypress Medical Products, Ltd.
|
Manual Mechanical Wheelchair, 20'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Co...
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2
|
03/22/2005
|
Cypress Medical Products, Ltd.
|
Manual Mechanical Wheelchair, 22'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Co...
|
2
|
03/22/2005
|
Cypress Medical Products, Ltd.
|
Catalog Number: 900633
FAN FOLD SHEET 44 X 58
Used by medical staff to perform surgical procedure...
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2
|
04/14/2016
|
Customed, Inc
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ORTHOPEDIC IMPLANT
PACK CUSTOMED USA, CODE 900-2903
CONTENTS:
(1) CAUTERY TIP POLISHER UF
...
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1
|
08/29/2014
|
Customed, Inc
|
Obstetrical Surgical pack,
code 900-2940, contains:
(1) BLANKET RECEIVING 100 COTTON
(3) TOWEL A...
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1
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08/29/2014
|
Customed, Inc
|
Drape Sheet, Product Code 2942, contains
(1) DRAPE % ECONOMY 53 X 77L/F
(1) WRAPPER 24 X 24 L/F
P...
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1
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08/29/2014
|
Customed, Inc
|
Face Pack- BOD, code 900-3027, contains:
(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill
(2) TOWELS...
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1
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08/29/2014
|
Customed, Inc
|
Liposuction Pack BOD, code 900-3028, contains:
(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill
(2) ...
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1
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08/29/2014
|
Customed, Inc
|
Face Lift , Code 900-3083, contains:
(I) SHEET ENT SPLIT 110" X 77" LIF
(I) COVER TABLE REINFORCED...
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1
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08/29/2014
|
Customed, Inc
|
Tummy Tuck Pack- FJG, code 900-3114, contains:
(2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill
(...
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1
|
08/29/2014
|
Customed, Inc
|
Liposuction Pack FJG, code 900-3115, contains:
(2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF...
|
1
|
08/29/2014
|
Customed, Inc
|
Face Pack FJG, code 900-3116, contains:
(2) GOWN LARGE STANDARD SMS AAMIIII
(2) TOWEL ABSORBENT 15...
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1
|
08/29/2014
|
Customed, Inc
|
Breast Pack- FJG, code 900-3118, contains:
(2) GOWN LARGE STANDARD SMS AAMIIII
(2) TOWEL ABSORBENT...
|
1
|
08/29/2014
|
Customed, Inc
|
Laparoscopy pack, , Code 900-3178, contains:
(1) BULB SYRINGE 60cc LIF
(10) GAUZE SPONGE 4" X 4" 1...
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1
|
08/29/2014
|
Customed, Inc
|
Breast pack TPSC, code 900-3431, contains:
(1) GOWN LARGE STANDARD SMS AAMIIII
(1) GOWN SOFT SMS S...
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1
|
08/29/2014
|
Customed, Inc
|
Open Heart Tray, Pack A, code 900-1196C, contains:
(1) TABLE COVER REINFORCED L/Free
(1) CARDIOVAS...
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1
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08/29/2014
|
Customed, Inc
|
UROLOGY PACK-
(10) GAUZE SPONGE 4" X 4" 16PLY
(1) TUBE SUCTION CONNECT Y." X12'
(1) SYRINGE 30c...
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1
|
08/29/2014
|
Customed, Inc
|
UNIVERSAL PACK -
(1) TRAY ORGANIZER FULL DEEP
(1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF
(1) SYRI...
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1
|
08/29/2014
|
Customed, Inc
|
LAPAROSCOPY CHOLE PACK -
(1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF
(2) SHEET DRAPE 42" X 5...
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1
|
08/29/2014
|
Customed, Inc
|
CESAREAN PACK -
(1) BABY BLANKET IMP. 30" X 30" POLY ABS.
(1) NEEDLE & BLADE COUNTER 60c FOAM/STR...
|
1
|
08/29/2014
|
Customed, Inc
|
O.B. PACK -
(I) TABLE COVER REINFORCED 50" X 90" LIF
(I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35"
...
|
1
|
08/29/2014
|
Customed, Inc
|
CESAREAN PACK -
(1) MAYO STAND COVER REINFORCED LIF
(5) TOWELS ABSORBENT LIF
(1) GOWN X-LARGE SM...
|
1
|
08/29/2014
|
Customed, Inc
|
MINOR LAPAROTOMY PACK -
(1) TABLE COVER 50" X 90" REINFORCED LIF
(1) GOWN SURG. X-LARGE REINFORC...
|
1
|
08/29/2014
|
Customed, Inc
|
UROLOGY PACK -
(3) TOWELS ABSORBENT 15" X 20" UF
(1) WASH BASIN ROUND 6QT.
(1) SYRINGE 30cc ...
|
1
|
08/29/2014
|
Customed, Inc
|
ARTHROSCOPY PACK-
(1) TABLE COVER REINFORCED 50" X 90"
(1) PRE PAD WITH CUFF
(2) GOWN XL SMS I...
|
1
|
08/29/2014
|
Customed, Inc
|
HIP ORTHOPEDIA PACK -
(1) BLADE SURGICAL #15 STAINLES /STEEL
(1) GOWN XL SMS IMPERVIOUS REINFORCE...
|
1
|
08/29/2014
|
Customed, Inc
|
BASIC PACK -
(1) TABLE COVER REINF. LIF
(1) MAYO STAND COVER REINF. LIF
(2) TOWELS ABSORBENT L...
|
1
|
08/29/2014
|
Customed, Inc
|