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

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    Galaxy System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    HEALIX TI PERMACORD

    FDA UDI
    Medos International Sàrl·10886705024841·HEALIX Ti ANCHOR w/ PERMACORD Titanium Anchor (...

    MicroPen EVO

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

    VIVO 50

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 4, 2024

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·July 31, 2017

    CD HORIZON SOLERA 5.5/6.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·January 15, 2025

    CD HORIZON SOLERA 5.5/6.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·September 9, 2024

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 16, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·September 15, 2015

    CD HORIZON SOLERA 5.5/6.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·January 25, 2025

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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