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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: 08/31/2015 510(K) Number: K101558
 
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Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. 2 Aug-29-2015 Biomet, Inc.
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control so... 2 Aug-29-2015 Bayer Healthcare, LLC
COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides th... 2 Aug-28-2015 Beckman Coulter Inc.
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model n... 3 Aug-28-2015 Abbott Electrophysiology
RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 106... 2 Aug-28-2015 Siemens Healthcare Diagnostics Inc
COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions... 2 Aug-28-2015 Beckman Coulter Inc.
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01,... 2 Aug-27-2015 Nidek Inc
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution. 2 Aug-27-2015 MRP, LLC dba AMUSA
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Vi... 2 Aug-27-2015 GE Healthcare
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software ... 2 Aug-27-2015 GE Healthcare

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