7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
FDA 510(k)
FDA Class 2
·Cardiovascular
Polyform Synthetic Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOMET CABLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SECHRIST GAS BLENDER MODEL 3500
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES·Product code BZR·April 15, 2014
ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·October 15, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012
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