10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
OCULAB TONOPEN
FDA 510(k)
FDA Class 2
·Ophthalmic
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124641·Modular Offset Stem 17mm x 75mm x 4mm
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209111350·KIT, ESSENTIALS - CUSTOM (vac)
Uni-C Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 30, 2012
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·September 27, 2010
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Recall
Open, Classified
·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025