7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CONQUEST FN
FDA 510(k)
FDA Class 2
·Orthopedic
TWINFIX FT PK
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 13, 2014
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 14, 2010
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 13, 2012
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024