9 results
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63ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVA Minimally Invasive System
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
FDA 510(k)
FDA Class 1
·Orthopedic
Procedure Mask, Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 24, 2021
IMPL TAPERED SP 3.7MM 10M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 1, 2024
EQUALIZER BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQY·November 19, 2008
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
SHCEIN PREMIUM 30G SHORT NEEDLE
FDA Adverse Event
Injury
·S.O.F.I.C. S.A.·Product code DZM·July 19, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025