9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
CATHETER, CEBTRAL VENOUS, 2N1501
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Kanso® Battery Cover
FDA UDI
COCHLEAR LIMITED·09321502035880·White
SURGICAL COLDLIGHT, AX8
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPILLARYS Hb A1c
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·November 27, 2024
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 24, 2014
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Injury
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·October 1, 2012
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 22, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025