7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE BIOPSY FORCEP
FDA 510(k)
FDA Class 2
·Neurology
CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISTA HPQ SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PULSE GEN MODEL 102
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code MUZ·July 20, 2015
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·December 14, 2010
PASSIVE PLUS DX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024