9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIGNA Hero
FDA 510(k)
FDA Class 2
·Radiology
HEALITE II SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
BERCHTOLD ELEKTROTOM 106 HITT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTIVELIFE 1 PC - 1PC DRAINABLE POUCH W/STOMAHESIVE (SH)
FDA Adverse Event
Injury
·CONVATEC DOMINICAN REPUBLIC, INC.·Product code EZQ·August 29, 2014
SENSATION CRESCENT STANDARD SNARE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FDI·October 23, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
DEKA SMARTPERIO
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019