11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
FDA 510(k)
FDA Class 3
·Cardiovascular
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837043520·Static Aileron Implant Caddy - Large
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007289·GLOBAL ENDURON PE SHOULDER - GLENOID PEG SIZE 52
MEDEOR MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NYCOCARD CRP
FDA 510(k)
FDA Class 2
·Immunology
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017
SYNERGY VERSITREL
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LGW·May 15, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 17, 2014
SHILEY CUFFED PEDIATRIC
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO·Product code JOH·June 2, 2011
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025