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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: 07/04/2014 510(K) Number: K101558
 
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Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue) and 8100005 D-TRON (anthraci... 1 Jun-25-2015 Disetronic Medical Systems, Inc.
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single... 1 Jun-24-2015 Teleflex Medical
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1... 1 Jun-13-2015 HeartWare Inc
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, ... 1 Jun-11-2015 HeartWare Inc
M/L Taper with Kinectiv® Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular... 1 Jun-08-2015 Zimmer, Inc.
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,11... 1 Jun-08-2015 HeartWare Inc
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalatio... 1 Jun-08-2015 Maquet Cardiovascular Us Sales, Llc
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, produ... 1 May-29-2015 Synovis Surgical Innovations, Inc.
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), int... 1 May-26-2015 Carefusion 211 Inc dba Carefusion
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended ... 1 May-14-2015 HeartWare Inc

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