8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Precice Max System
FDA 510(k)
FDA Class 2
·Orthopedic
NEWTRON P5, NEWTRON P5 B.LED
FDA 510(k)
FDA Class 2
·Dental
R&D DESIGNATION AP-052-5
FDA 510(k)
FDA Class 2
·Dental
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 17, 2016
UNKNOWN DEPUY HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 13, 2008
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011
GORE DRYSEAL SHEATH
FDA Adverse Event
Injury
·W. L. GORE ASSOCIATES INC.·Product code DYB·July 9, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025