9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ACCESS R-CLONE ANA PROFILE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
NEPHROSTOMY DRAINAGE CATHETER & STIFFENER
FDA 510(k)
FDA Unclassified
·Unknown
NORELCO DIGITAL BLOOD PRESSURE METER HC3001
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
ANATOMICAL SHOULDER¿¢, GLENOID, PEGGED, CEMENTED, M
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSD·February 18, 2025
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 19, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·December 18, 2012
RIGIDFIX ST FEMORAL GUIDE FRAME
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code NBH·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