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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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QuietCare.
Intended for use in monitoring the environmental conditions and activity (motion) of a...
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2
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05/24/2013
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Intel-GE Care Innovations LLC
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Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12.
Product ...
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2
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05/15/2013
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Iris Diagnostics
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BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 ...
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2
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05/03/2013
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Becton Dickinson & Co.
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Newport Medical Instruments HT70
and HT70 Plus ventilator Power Pac batteries Model number: HT70 a...
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1
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04/26/2013
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Newport Medical Instruments Inc
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The Alere Cholestech LDX® high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12...
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2
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04/25/2013
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Alere San Diego, Inc.
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GE Healthcare, Xeleris 2 Processing & Review Workstation.
The display, processing, archiving, and...
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2
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04/23/2013
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GE Healthcare, LLC
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Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3
The infor...
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2
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04/12/2013
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Siemens Medical Solutions USA, Inc
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LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002.
...
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3
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04/10/2013
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Lighthouse For The Blind
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Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use...
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1
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03/02/2013
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Ad-Tech Medical Instrument Corporation
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Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and ...
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2
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02/13/2013
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CHENICA INC.
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Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM...
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2
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02/04/2013
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Zimmer, Inc.
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Trilogy F/M Acetabular Shell with Uni-Hole.
The Trilogy Acetabular System is indicated for either...
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2
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02/04/2013
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Zimmer, Inc.
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Trilogy Acetabular AB Shells with Holes.
The Trilogy Acetabular System is indicated for either ce...
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2
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02/04/2013
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Zimmer, Inc.
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Trilogy Acetabular Shell with Cluster Holes.
The Trilogy Acetabular System is indicated for eithe...
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2
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02/04/2013
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Zimmer, Inc.
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Trilogy Acetabular AB Shells with Cluster Holes.
The Trilogy Acetabular System is indicated for e...
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2
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02/04/2013
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Zimmer, Inc.
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Trilogy Acetabular Shells with Holes.
The Trilogy Acetabular System is indicated for either cemen...
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2
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02/04/2013
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Zimmer, Inc.
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Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, ...
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2
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02/04/2013
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Zimmer, Inc.
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Trilogy Acetabular Shell Spiked.
The Trilogy Acetabular System is indicated for either cemented o...
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2
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02/04/2013
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Zimmer, Inc.
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45® Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031.
Model #:
P2...
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2
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01/30/2013
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Greatbatch Medical
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Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument.
Nd:YAG 1064 nm: Coag...
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2
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01/17/2013
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Quanta System, S.p.A.
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GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Di...
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1
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12/26/2012
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GE Healthcare, LLC
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Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a requir...
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1
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12/14/2012
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Bunnell, Inc.
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Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine periphe...
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2
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12/07/2012
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Hospira Inc.
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Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Eng...
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2
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12/07/2012
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Hospira Inc.
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Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination o...
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2
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12/03/2012
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Sekisui Diagnostics Llc
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Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere,...
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2
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11/21/2012
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Biomet, Inc.
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The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile
The Trilogy...
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2
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11/21/2012
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Zimmer, Inc.
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Hoffman LRF Telescopic Strut Short
Stryker
Stryker Trauma AG
CH-2545 Seizach
Distributed in the ...
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2
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11/08/2012
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Stryker Howmedica Osteonics Corp.
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HiRes 90K devices with Helix Electrodes Model CI 1400-02H
The HiResolution Bionic Ear System is a...
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2
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10/22/2012
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Advanced Bionics Corporation
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AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255.
The AutoMate 1200/2500 Syste...
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2
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10/12/2012
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Beckman Coulter Inc.
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IDS-iSYS N-Mid® Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bo...
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2
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10/10/2012
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Immunodiagnostics Systems Ltd
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IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box ...
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2
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10/10/2012
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Immunodiagnostics Systems Ltd
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8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged indi...
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2
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10/04/2012
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C.R. Bard, Inc., Urological Division
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Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually...
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2
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10/02/2012
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Cure Medical LLC
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Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035.
...
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2
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09/26/2012
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Invacare Corporation
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SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutop...
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2
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09/24/2012
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RAYSEARCH LABORATORIES AB
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Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activat...
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2
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09/20/2012
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Sekisui Diagnostics Llc
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The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220...
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2
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09/17/2012
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Bio-Rad Laboratories
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The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To det...
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2
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09/14/2012
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RAYSEARCH LABORATORIES AB
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Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System
Catalog Number DC...
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2
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09/13/2012
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Capsule Tech Inc.
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VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD wi...
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3
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09/06/2012
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Trek Diagnostic Systems
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BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, In...
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2
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09/06/2012
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Becton Dickinson & Co.
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Capintec Captus 3000 Thyroid Uptake System
Nuclear uptake probe intended to be used by trained N...
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2
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09/05/2012
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Capintec Inc
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OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with ...
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2
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09/04/2012
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Exactech, Inc.
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V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490
Product Usage:
The V60 Ventilator ...
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1
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08/31/2012
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Respironics California Inc
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Various SRI Surgical Disposable Accessory Packs.
SRI's Disposable Accessory Packs (also commonly ...
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2
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08/29/2012
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SRI Surgical
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OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak P...
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1
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08/28/2012
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GE OEC Medical Systems, Inc
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OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomi...
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2
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08/22/2012
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GE OEC Medical Systems, Inc
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EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integra...
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2
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08/22/2012
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Siemens Healthcare Diagnostics, Inc.
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Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16...
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2
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08/22/2012
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Philips Medical Systems (Cleveland) Inc
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