8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CORITSOL PREMIX RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750030163·VITROS Chemistry Products HCY 2 Performance Ver...
DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ideal pedicle screw spinal system
FDA 510(k)
FDA Class 2
·Orthopedic
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD .·Product code MCM·June 2, 2014
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 21, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2015
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021