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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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OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected...
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2
|
06/22/2006
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bioMerieux Inc
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***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only*...
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2
|
08/08/2012
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Biomet 3i, LLC
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***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx On...
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2
|
11/08/2011
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Biomet 3i, LLC
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"***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERIL...
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3
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07/13/2011
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Biomet 3i, LLC
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***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***B...
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2
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05/24/2011
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Biomet 3i, LLC
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***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET...
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2
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05/04/2011
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Biomet 3i, LLC
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Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, ...
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2
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10/05/2011
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Biomet Microfixation, Inc.
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Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfi...
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2
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05/27/2009
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Biomet Microfixation, Inc.
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10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230.
...
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2
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03/25/2016
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Biomet Spine, LLC
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HipLOC Hip Fracture Fixation System-Hiploc System 135® Plate 38 mm Barrel 3 Hole Plate
Item Numbe...
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2
|
09/27/2018
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Biomet UK Ltd.
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HipLOC Hip Fracture Fixation System- Hiploc System 130® Plate 38 mm Barrel 4 Hole Plate
Item Number...
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2
|
09/27/2018
|
Biomet UK Ltd.
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HipLOC Hip Fracture Fixation System-Hiploc System 135® Plate 38 mm Barrel 4 Hole Plate
Item Number:...
|
2
|
09/27/2018
|
Biomet UK Ltd.
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HipLOC Hip Fracture Fixation System-Hiploc System 140® Plate 38 mm Barrel 4 Hole Plate
Item Number:...
|
2
|
09/27/2018
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Biomet UK Ltd.
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Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product ...
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2
|
04/22/2024
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Biomet, Inc.
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Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 14122...
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2
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04/28/2011
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Biomet, Inc.
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Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141...
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2
|
04/28/2011
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Biomet, Inc.
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Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Produ...
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2
|
11/24/2007
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Biomet, Inc.
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CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, ...
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2
|
03/17/2010
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Boston Scientific Corp
|
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm
UPN: M00536730
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2
|
11/25/2019
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Boston Scientific Corporation
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Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
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2
|
11/25/2019
|
Boston Scientific Corporation
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Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm
UPN: M00536710
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2
|
11/25/2019
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Boston Scientific Corporation
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Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm
UPN: M00536700
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2
|
11/25/2019
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Boston Scientific Corporation
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Boston Scientific Advanix Pancreatic Stent, Straight
Leading Barb, 10F x 3cm
UPN: M00536610
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2
|
11/25/2019
|
Boston Scientific Corporation
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Boston Advanix Pancreatic Stent, Straight
Leading Barb, 10F x 4cm
UPN: M00536620
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2
|
11/25/2019
|
Boston Scientific Corporation
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Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm
UPN: M00536630
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2
|
11/25/2019
|
Boston Scientific Corporation
|
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm
UPN: M005337206
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2
|
11/25/2019
|
Boston Scientific Corporation
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Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm
UPN: M00536650
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2
|
11/25/2019
|
Boston Scientific Corporation
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Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm
UPN: M00536660
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2
|
11/25/2019
|
Boston Scientific Corporation
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Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm
UPN: M00536670
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2
|
11/25/2019
|
Boston Scientific Corporation
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Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm
UPN: M005336680
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2
|
11/25/2019
|
Boston Scientific Corporation
|
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm
UPN: M005336690
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2
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11/25/2019
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Boston Scientific Corporation
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Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Irel...
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2
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04/11/2012
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Boston Scientific Corporation
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Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent,...
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2
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07/15/2011
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Boston Scientific Corporation
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Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stai...
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1
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07/27/2004
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Boston Scientific Corporation
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AmediCheck Instant Test Cup, Part No. C-C0501A-3A
Product Usage:
The AmediCheck Instant Test Cup...
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3
|
08/01/2016
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Branan Medical Corporation
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Dressing M/U XL, P/N 02344
Product Usage:
These products are sterile dressings used as an insula...
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2
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05/02/2017
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Breg Inc
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Dressing Rect L, P/N 02428
Product Usage:
These products are sterile dressings used as an insula...
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2
|
05/02/2017
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Breg Inc
|
Dressing Knee/Shldr, P/N 02328
Product Usage:
These products are sterile dressings used as an in...
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2
|
05/02/2017
|
Breg Inc
|
Dressing, Knee L/XL, P/N 04708
Product Usage:
These products are sterile dressings used as an in...
|
2
|
05/02/2017
|
Breg Inc
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Dressing Shldr, P/N 04908
Product Usage:
These products are sterile dressings used as an insulat...
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2
|
05/02/2017
|
Breg Inc
|
Dressing Shldr XL, P/N 04918
Product Usage:
These products are sterile dressings used as an insu...
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2
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05/02/2017
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Breg Inc
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Dressing Back, P/N 09810
Product Usage:
These products are sterile dressings used as an insulati...
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2
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05/02/2017
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Breg Inc
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If Hip, Sterile Polar Dressing P/N 10680
Product Usage:
These products are sterile dressings use...
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2
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05/02/2017
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Breg Inc
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Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630
Used with cold therapy pads to provide i...
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2
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09/06/2012
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Breg Inc, An Orthofix Company
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Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment devic...
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2
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07/06/2015
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BTE Technologies, Inc.
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Lumbar Tray
Catalog 1091
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2
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05/28/2022
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Busse Hospital Disposables, Inc.
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Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed ...
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2
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11/19/2011
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C P Medical Inc.
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Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed ...
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2
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11/19/2011
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C P Medical Inc.
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Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF ...
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2
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09/17/2009
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C R Bard Inc
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Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF ...
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2
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09/17/2009
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C R Bard Inc
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Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF ...
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2
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09/17/2009
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C R Bard Inc
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Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON STERILE, REF ...
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2
|
09/17/2009
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C R Bard Inc
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Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, ...
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2
|
09/17/2009
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00204W, 20F x 1.7cm, 10cc, Sterile ...
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2
|
04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm, 10cc, Sterile ...
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2
|
04/08/2009
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm, 10cc, Sterile ...
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2
|
04/08/2009
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00223W, 18F x 2.4cm, 10cc, Sterile ...
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2
|
04/08/2009
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm, 10cc, Sterile ...
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2
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04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc, Sterile ...
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2
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04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm, 20cc, Sterile ...
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2
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04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm, 20cc, Sterile ...
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2
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04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00217W, 24F x 2.4cm, 20cc, Sterile ...
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2
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04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00216W, 24F x 1.7cm, 20cc, Sterile ...
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2
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04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile ...
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2
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04/08/2009
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm, 20cc, Sterile ...
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2
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04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00213W, 20F x 2.4cm, 20cc, Sterile ...
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2
|
04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm, 20cc, Sterile ...
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2
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04/08/2009
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C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00210, 16F x 2.4cm, 20cc, Sterile E...
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2
|
04/08/2009
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00207W, 20F x 4.4cm, 10cc, Sterile ...
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2
|
04/08/2009
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00206W, 20F x 3.4cm, 10cc, Sterile ...
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2
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04/08/2009
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00205W, 20F x 2.4cm, 10cc, Sterile ...
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2
|
04/08/2009
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm, 10cc, Sterile ...
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2
|
04/08/2009
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm, 10cc, Sterile ...
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2
|
04/08/2009
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc, Sterile ...
|
2
|
04/08/2009
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm, 10cc, Sterile ...
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2
|
04/08/2009
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00223W, 18F, 2.4cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00206W, 20F, 3.4cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00207W, 20F, 4.4cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00209W, 16F, 1.7cm, 20cc, Sterile ...
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2
|
12/12/2008
|
C R Bard Inc
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00210W, 16F, 2.4cm, 20cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00212W, 20F, 1.7cm, 20cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00213W, 20F, 2.4cm, 20cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F, 1.2cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00225W, 18F, 4.4cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00224W, 18F, 3.4cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00205W, 20F, 2.4cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00222W, 18F, 1.7cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00221W, 18F, 1.2cm, 10cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00219W, 24F, 4.4cm, 20cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00218W, 24F, 3.4cm, 20cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00217W, 24F, 2.4cm, 20cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00216W, 24F, 1.7cm, 20cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00215W, 20F, 4.4cm, 20cc, Sterile ...
|
2
|
12/12/2008
|
C R Bard Inc
|
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00214W, 20F, 3.4cm, 20cc, Sterile ...
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2
|
12/12/2008
|
C R Bard Inc
|
7F Bard SSV 13 cm Split Sheath with Valve and sideport
Catalog Number: 808700
Distributed By: Bard...
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2
|
11/07/2008
|
C. R.Bard, Inc./BardElectrophysiology Division
|
Bard Orbiter ST Artrial Mapping Steerable Catheter
Item Numbers
320001 7FAM00001 7FAM00010 7FAM000...
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2
|
02/28/2003
|
C. R.Bard, Inc./Electrophysiology Division
|