7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
POTASSIUM HYDROXIDE 10% W/V
FDA 510(k)
FDA Class 1
·Pathology
SYSTEM 12 CONSTRAINED ACETABULAR LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
Pobling MIITY 2
FDA 510(k)
FDA Class 2
·Neurology
ACCU-CHEK ® ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FPA·June 10, 2014
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 10, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 23, 2015
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020