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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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enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, ,...
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2
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11/02/2010
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Greatbatch Medical
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enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, ...
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2
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01/26/2012
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Ortho-Clinical Diagnostics
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enGen Track System with enGen Select v5.0 with autoverification enabled
Product The VITROS 5,1 FS...
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2
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02/09/2014
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Ortho-Clinical Diagnostics
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enGen Track System with enGen Custom v3.2.2 (& below)
Product The VITROS 5,1 FS Chemistry System ...
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2
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02/09/2014
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Ortho-Clinical Diagnostics
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enFlow IV Fluid Warmer Part number 980105VS;
(510K name: enFlow IV Fluid Warmer Model 100, EFlow Di...
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2
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08/19/2011
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Vital Signs Devices, a GE Healthcare Company
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enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL
100, EFLOW DISPOSABLE CARTRIDGE, MO...
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2
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07/09/2012
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Vital Signs Devices, a GE Healthcare Company
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embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder).
...
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2
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06/11/2013
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Embla System Llc
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eSwallow Multi-Program Dysphagia Therapy Test unit
Intended Use: Powered Muscle Stimulator for t...
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2
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07/25/2011
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eSwallow USA LLC
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e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; ...
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2
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10/24/2003
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Siemens Medical Solutions USA, Inc.
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e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; ...
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2
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03/06/2003
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Siemens Medical Solutions USA, Inc.
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