9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Trivicta® Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251052400·ceraMotion® Ti Dentin C3, 40 g / dental ceramic...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251052200·ceraMotion® Ti Dentin C3, 20 g / dental ceramic...
KLS Martin Individual Patient Solutions (IPS) Planning System
FDA 510(k)
FDA Class 2
·Neurology
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 14, 2014
POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MJO·September 12, 2011
ELLIPS FX PHACO HANDPIECE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQC·July 29, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025