9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EZEE FILTER/SEPARATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CYBER TM FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·May 23, 2014
SERIES 7000 TIBIAL TRAY IMPLANT
FDA Adverse Event
Injury
·STRYKER ORHTOPAEDICS MAHWAH·Product code JWH·November 2, 2012
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018