7 results
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16ms
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Sources: EU EUDAMED, US FDA
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MULTILASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183
FDA 510(k)
FDA Class 2
·Orthopedic
BE-PLS 2050 PERMANENT LIFE SUPPORT
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 20, 2014
ART OF CARE RECLINER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FRJ·October 10, 2012
SOFTCLIX® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 2, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024