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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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Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Gr...
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2
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08/30/2011
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Covidien, PLC
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Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro dia...
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2
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08/19/2011
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Siemens Healthcare Diagnostics, Inc.
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Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case.
Sterile, D...
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2
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08/10/2011
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North Coast Medi-Tek Inc
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Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corpo...
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2
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08/08/2011
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Baxter Healthcare Corp.
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Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corpo...
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2
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07/19/2011
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Baxter Healthcare Corp.
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Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthc...
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2
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07/13/2011
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Baxter Healthcare Corp.
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Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic...
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2
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07/13/2011
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Terumo Medical Corporation
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DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM ...
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2
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07/11/2011
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Medtronic Navigation, Inc.
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syngo Dynamics Picture Archiving Communication System
The software is a picture archiving and com...
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2
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07/08/2011
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Siemens Medical Solutions, USA, Inc
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BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling
***smith&nephew ***#420400***...
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2
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07/06/2011
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Smith & Nephew Inc.
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iView DAB Detection Kit, Part number: 760-091
(05266157001)
This detection kit is intended for i...
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2
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07/01/2011
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Ventana Medical Systems Inc
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ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001)
This detection kit is i...
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2
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07/01/2011
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Ventana Medical Systems Inc
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LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, ...
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2
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06/28/2011
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LINA Medical ApS
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LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, ...
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2
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06/28/2011
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LINA Medical ApS
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LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8...
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2
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06/28/2011
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LINA Medical ApS
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1500T14 Cardiac Ablation System - Generator
The 1500Tl4 Cardiac Ablation System operates in conju...
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2
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06/23/2011
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St Jude Medical
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COBAS® AmpliPrep / COBAS® TaqMan® HCV Test, US-IVD
The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test i...
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2
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06/17/2011
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Roche Molecular Systems, Inc.
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Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shie...
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2
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06/10/2011
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Medela Inc
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IMPAX CV (Cardio Vascular)
The IMPAX Cardiovascular suite is a cardiovascular information system,...
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2
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06/10/2011
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AGFA Corp.
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Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement ...
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2
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06/08/2011
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Hitachi Medical Systems America Inc
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Newport HT70 Ventilator. Model #HT70,
The Newport HT70 ventilator is intended to provide conti...
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2
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06/02/2011
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Newport Medical Instruments Inc
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Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System.
Catalog Number: DC-NU-M...
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2
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06/01/2011
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Capsule Tech Inc.
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Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B
Product Code: NOU
Th...
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2
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05/27/2011
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Newport Medical Instruments Inc
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Newport HT50 Ventilator.
Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B.
The device is inten...
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2
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05/26/2011
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Newport Medical Instruments Inc
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Newport HT50® Ventilator. Model #HT50 H1-B
The device is intended to provide continuous or int...
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2
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05/26/2011
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Newport Medical Instruments Inc
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syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI.
The syngo Dynami...
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2
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05/25/2011
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Siemens Medical Solutions, USA, Inc
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IMPAX 6.5 Client Software.
IMPAX 6.5 combines the traditional activities of RIS informatics manag...
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2
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05/24/2011
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AGFA Corp.
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Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sampl...
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2
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05/20/2011
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Salter Laboratories, Division of Regulatory Affairs
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Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion ...
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2
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05/19/2011
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Baxter Healthcare Corp.
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Access Immunoassay Systems Thyroglobulin,
Part Number: 33860
This device is intended to aid in m...
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2
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05/19/2011
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Beckman Coulter Inc.
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Software CD is labeled in part:
"BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Softw...
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2
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05/19/2011
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Bio-Rad Laboratories
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Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Ki...
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2
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05/13/2011
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Digisonics, Inc
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Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numb...
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2
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05/10/2011
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Beckman Coulter Inc.
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DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240.
Digiview...
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2
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05/10/2011
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Digisonics, Inc
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Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 ...
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2
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05/10/2011
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Digisonics, Inc
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NX is the radiographer's image identification and quality control tool. It offers a broad array of f...
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2
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05/04/2011
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AGFA Corp.
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CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer.
Abbott Diagnostics Division, Santa ...
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2
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04/29/2011
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Abbott Laboratories
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CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb)...
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2
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04/29/2011
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Abbott Laboratories
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CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb)...
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2
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04/29/2011
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Abbott Laboratories
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CELL-DYN Sheer Valve Assembly Driver
Abbott Diagnostics Division, Santa Clara, CA 05054
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2
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04/29/2011
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Abbott Laboratories
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CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb)...
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2
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04/29/2011
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Abbott Laboratories
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CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb)...
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2
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04/29/2011
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Abbott Laboratories
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CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb)...
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2
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04/29/2011
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Abbott Laboratories
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Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh,...
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2
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04/14/2011
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Arjo, Inc. dba ArjoHuntleigh
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Penner Manufacturing Bariatric Patient Transfer/Lift System, Cascade Transfer, Models 382500-1 (righ...
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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 Cascade Patient Transfer/Lift System, Models 382000-1 (right ...
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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 Patient Transfer/Lift System, Cascade Transfer, Models 380000-1 (white) and 380...
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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, Patient Transfer/Lift System, Models 393000-1...
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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 Cascade with Scale, Patient Transfer/Lift System, Models 383...
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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 Bariatric with Scale, Patient Transfer/Lift System, Cascade T...
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2
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04/08/2011
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Penner Mfg Inc
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