10 results
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17ms
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Sources: EU EUDAMED, US FDA
PRECEPT AVGMENTIN
FDA 510(k)
FDA Class 2
·Microbiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209117390·
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
FDA 510(k)
FDA Class 2
·Cardiovascular
Aquilion Lightning, TSX-035A/4 and /5, V7.0
FDA 510(k)
FDA Class 2
·Radiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTH CORPORATION·Product code FRN·January 23, 2014
*
FDA Adverse Event
Malfunction
·ARTHROCARE·Product code KOG·November 27, 2012
3D KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code MBH·September 30, 2010
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015