7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COBAS(R) CORE IGE TOTAL EIA
FDA 510(k)
FDA Class 2
·Immunology
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
SWITCHBLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 16, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·Product code OZO·July 12, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020