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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 500 Results *
Date Classified to: 04/23/2014 PMA Number: P980040/S015
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Product Description
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iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Product Usage: The iLab Ultraso... 2 Apr-22-2014 Boston Scientific Corporation
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTD... 2 Apr-22-2014 Merit Medical Systems, Inc.
Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (... 2 Apr-22-2014 Merit Medical Systems, Inc.
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Resea... 2 Apr-21-2014 Hospira Inc.
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w... 2 Apr-21-2014 GE Healthcare, LLC
Radiation Therapy Treatment Planning System, Stand-alone software. Product Usage: RayStation is ... 2 Apr-21-2014 RAYSEARCH LABORATORIES AB
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040... 2 Apr-18-2014 Pega Medical Inc.
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a varie... 2 Apr-18-2014 Remel Inc
API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API... 2 Apr-18-2014 BioMerieux SA
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some m... 2 Apr-18-2014 BioMerieux SA

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