10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Omega VL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BI-METRIC REVISION HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304006980·
Bi-Metric® Revision Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868261558·
BI-METRIC(R) HEAD/NECK PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307582·
FINESS ENDOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OPTIME, SINUSORB PGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·July 14, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 11, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 9, 2008
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021