11 results
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26ms
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Sources: EU EUDAMED, US FDA
IMPLANTABLE CLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
artegral
FDA UDI
Merz Dental GmbH·D7091970793·anteriors; shade BL3; mould UBIM
SBI DISTAL RADIUS VOLAR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SuRgical Planner (SRP)
FDA 510(k)
FDA Class 2
·Radiology
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·November 7, 2013
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVAMEX·Product code FSA·February 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 25, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 8, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 28, 2016
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
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024