10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
WRINKLE CHAPEAU BLACKY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LEONE SPA
FDA UDI
LEONE SPA·08033707058427·DB TUBE MIM CONV 22/51 T-10 R+8 UR
LEONE SPA
FDA UDI
LEONE SPA·08033707064930·TUBE MIM CONV 22/51 T-10 R+8 UR
ALIANS ULNA LOCKING PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
3 SERIES PHOTOTHERAPY CABINET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTETRAK KNEE COMPONENT - TIBIAL INSERT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 19, 2024
5MM, 33CM PEEK MONOPOLAR HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·June 2, 2014
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·November 21, 2012
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 31, 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