BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517148315·Helix-R Plate-Hold DTS Guide Tray, Base

    VistaTablet

    FDA UDI
    Vital Connect, Inc.·00850490007399·Vista Tablet relay device

    TSRH® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978042312·CROSSLINK 810-301 5.5MM LP L .625

    IMMUNOWELL EA (D) IGG TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SILK'N FX

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

    Coselgi

    FDA UDI
    Widex A/S·05706069520460·Coselgi Melodia 15 CMe15-M (Titan grey ) RC coil

    Coselgi

    FDA UDI
    Widex A/S·05706069520477·Coselgi Melodia 15 CMe15-M (Midnight black ) RC...

    Coselgi

    FDA UDI
    Widex A/S·05706069520453·Coselgi Melodia 15 CMe15-M (Warm beige ) RC coil

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 10, 2014

    PROGENIX DBM PUTTY

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NUN·October 31, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 2, 2015

    PUMP MMT-1781KL 670G MG RPL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 19, 2022

    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017