8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SORBIES
FDA 510(k)
FDA Class 1
·General Hospital
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PDT-FACE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 10, 2014
L122UV ANTERIOR CHAMBER INTRAOCULAR LENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQL·October 12, 2012
KAPPA 400 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 10, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025