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U.S. Department of Health and Human Services

Medical Device Recalls
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The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist ... 2 04/10/2017 Merit Medical Systems, Inc.
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal... 1 04/07/2017 Medtronic Neurosurgery
The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and re... 2 09/26/2013 Stryker Medical Division of Stryker Corporation
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Sto... 2 07/06/2017 Mallinckrodt Manufacturing LLC
TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: ... 2 08/19/2011 Medtronic Sofamor Danek USA Inc
TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are intended to provide immobiliz... 2 09/01/2010 Synthes USA (HQ), Inc.
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET ... 2 09/25/2013 Maquet Cardiovascular Us Sales, Llc
TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15... 2 04/04/2011 Siemens Medical Solutions USA, Inc.
T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of ... 2 07/16/2018 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjust... 2 02/04/2013 Synthes USA HQ, Inc.

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