7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
FDA 510(k)
FDA Class 2
·Cardiovascular
HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
PROMUS ELEMENT? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 26, 2014
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·November 11, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 4, 2013
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