BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    HUMID-VENT HEPA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BREATHING CIRCUIT FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PHILIPS AVALON FETAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013

    EXTENDED COATED BLADE

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 1, 2009

    EXTENDED COATED BLADE

    FDA Adverse Event
    Injury ·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 1, 2009

    AUTOPULSE LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·June 3, 2011

    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

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025