8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GIFT CATHETER SET/S
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ISKRA MEDICAL GREEN IRF PRESTIGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 28, 2013
DURALOC SECTOR SERIES 54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 31, 2011
BEQ-HMOD70000-USA-QUADROX-ID OXYGENATOR
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 1, 2014
BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024