BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    RENASYS AB ABOMINAL DRESSING KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    8200 VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00817136020044·8227C CO2 Reb Vlv Setup w/2700

    CIRRUS PHOTO

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VENUS SWAN SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FNL·May 14, 2013

    UNKNOWN DEPUY FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KXA·May 18, 2011

    I-STAT CTNI CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·August 5, 2008

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 27, 2018

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 8, 2016

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 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