8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
HemosIL Silica Clotting Time
FDA 510(k)
FDA Class 2
·Hematology
Demetra Dermatoscope BDEM-01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOALEX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 5, 2023
VITALITY VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
SIGN SERIES IV STEP SCREW
FDA Adverse Event
Injury
·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·September 14, 2011
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·July 30, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025