8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BIOTROL URINE PROTEINS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403152986·Snowden-Pencer ENDOPLASTIC DISSECTOR HALF CURVE...
SERA-TEK MICROSOMAL ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
THABEST-IGE
FDA 510(k)
FDA Class 2
·Immunology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 19, 2014
COBLATOR II
FDA Adverse Event
Injury
·ARTHROCARE CORPORATION·Product code GEI·December 19, 2012
OMNISPAN 0 DEGREE MENISCAL FASTENER
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·October 20, 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