8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WESTON RECTAL SNARE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PLAYTEX COMBINATION FIBER MODIFIED TAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoLink NeoFuse MIS Plating System (see attached parts list)
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·May 30, 2014
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 21, 2012
OASYS TRANSVERSE CONNECTOR 60MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWP·September 7, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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