8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CHIN (MENTOPLASTY) IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES SMALL COBINATION CLAMP-MR SAFE
FDA 510(k)
FDA Class 2
·Orthopedic
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014
EGR SYSTEM (STERILE)
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code NBH·November 9, 2012
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·January 8, 2008
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025