BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    CATALYST

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTEL HEALTH GUIDE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code PJS·March 18, 2025

    BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)

    FDA Adverse Event
    Injury ·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 26, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    CARPENTIER-EDWARDS PORCINE MITRAL VALVE SIZE 25

    FDA Adverse Event
    Other ·JOHNSON AND JOHNSON·Product code DYE·May 17, 2011

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025