12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CarboClear® X Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·September 4, 2014
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 4, 2014
SUMMIT POR TAPER SZ7 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·March 4, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 6, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 3, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 18, 2013
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 4, 2012
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 4, 2012
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025