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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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Penner Manufacturing Transfer Electric Superior right entry, Patient Transfer/Lift System, Models 3...
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2
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04/08/2011
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Penner Mfg Inc
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Penner Manufacturing Transfer Electric Superior left entry, Patient Transfer/Lift System, Models 38...
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2
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04/08/2011
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Penner Mfg Inc
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Penner Manufacturing Transfer Electric Superior end entry, Patient Transfer/Lift System, Models 386...
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2
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04/08/2011
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Penner Mfg Inc
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Penner Manufacturing Transfer Electric Superior right entry with scale, Patient Transfer/Lift System...
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2
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04/08/2011
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Penner Mfg Inc
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Penner Manufacturing Transfer Electric Superior left entry with scale, Patient Transfer/Lift System,...
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2
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04/08/2011
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Penner Mfg Inc
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Penner Manufacturing Transfer Electric Superior end entry with scale, Patient Transfer/Lift System, ...
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2
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04/08/2011
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Penner Mfg Inc
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Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift System, Mode...
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2
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04/08/2011
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Penner Mfg Inc
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iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4...
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2
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04/04/2011
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Philips Medical Systems
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The enGenTM Laboratory Automation System consists of 3 main components including Instrument Manageme...
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2
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03/28/2011
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Ortho-Clinical Diagnostics
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Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin s...
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2
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03/23/2011
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Organogenesis, Inc.
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Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin ...
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2
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03/23/2011
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Organogenesis, Inc.
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TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulatio...
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2
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03/21/2011
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Haemoscope Division of Haemonetics Corp
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Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is man...
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2
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03/18/2011
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Abbott Laboratories
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Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02,
Product is manufactur...
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2
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03/17/2011
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Abbott Laboratories
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Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Sample Loader)...
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2
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03/17/2011
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Abbott Laboratories
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Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Man...
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2
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03/17/2011
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Abbott Laboratories
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Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manu...
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2
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03/17/2011
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Abbott Laboratories
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Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Manufactured by Abbott Dia...
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2
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03/17/2011
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Abbott Laboratories
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Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott Diagnostics D...
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2
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03/17/2011
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Abbott Laboratories
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CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analy...
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2
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03/11/2011
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Abbott Laboratories
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VCare® Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per c...
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3
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03/03/2011
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ConMed Corporation
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Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and i...
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2
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03/02/2011
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Integra LifeSciences Corp.
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IMPAX CV Results Manager/Results Manager Administration Tool
The IMPAX Cardiovascular suite is a ...
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2
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02/25/2011
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AGFA Corp.
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Cardiovascular Review Station
The IMPAX Cardiovascular suite is a cardiovascular information syst...
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2
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02/24/2011
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AGFA Corp.
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Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom ...
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2
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02/23/2011
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Hill-Rom, Inc.
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Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60...
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3
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02/23/2011
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Abbott Molecular
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Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ...
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3
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02/23/2011
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Abbott Molecular
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AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compoun...
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2
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02/22/2011
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Baxter Healthcare Corp.
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AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compou...
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2
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02/22/2011
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Baxter Healthcare Corp.
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AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Baxter Health...
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2
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02/22/2011
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Baxter Healthcare Corp.
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AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Baxter H...
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2
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02/22/2011
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Baxter Healthcare Corp.
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Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in opht...
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2
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02/16/2011
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Aspen Surgical Products, Inc.
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Celite ACT Cartridge
Cartridge is useful for monitoring patients receiving heparin for treatment ...
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2
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02/16/2011
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Abbott Point Of Care Inc.
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Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0
The display, processing, archiving, ...
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2
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02/15/2011
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GE Healthcare, LLC
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Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System;
List Number: 09H39-0...
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2
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02/10/2011
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Abbott Laboratories
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Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manu...
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2
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02/01/2011
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Optovue Inc.
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Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covid...
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2
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01/25/2011
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Covidien LP
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Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthc...
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2
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01/21/2011
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Baxter Healthcare Corp.
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Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication ...
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2
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01/21/2011
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Baxter Healthcare Corp.
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Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Di...
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2
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01/21/2011
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Baxter Healthcare Corp.
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Mammography Keypad
Radiologists and Technologist apply hotkeys from a keyboard for ease of use in t...
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3
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12/29/2010
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AGFA Corp.
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Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01
...
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2
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12/21/2010
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Advanced Bionics Corporation
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Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H
...
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2
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12/21/2010
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Advanced Bionics Corporation
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ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the...
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2
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12/16/2010
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Abbott Laboratories
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XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION
The display, processing, archiving,...
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2
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12/03/2010
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GE Healthcare, LLC
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CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers;
CEL...
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2
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11/29/2010
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Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
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Innova 2000 The principle system components include a C-arm, image acquisition, processing and archi...
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2
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11/16/2010
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GE Healthcare, LLC
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AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 59044...
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2
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10/26/2010
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Siemens Medical Solutions USA, Inc
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EasyLink Informatics Systems QCFIRST Custom Rule
The EasyLink Informatics System is classified as a...
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2
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10/21/2010
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Siemens Healthcare Diagnostics, Inc.
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SoftPath GUI Releases 3.17 through 4.1.0.
SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 3...
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2
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10/15/2010
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SCC Soft Computer
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