9 results
·
33ms
·
Sources: EU EUDAMED, US FDA
BATEMAN UPF II HIP PROSTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Fisherbrand
FDA UDI
FISHER SCIENTIFIC COMPANY L.L.C.·00613647010037·DISSECTING SCISSORS 6 INCH
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690197324·AK3 PS-R Insert Trial Size 1, 20mm
ATI DISPOSABLE BIOLOGICAL TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
ESI MODEL MS-103
FDA 510(k)
FDA Class 2
·Neurology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 25, 2014
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 3, 2013
M2A 38MM FLARED ONE-PIECE CUP 38MM ID X 60MM OD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 10, 2010
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020