BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    CryoLab

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768512·GENUMEDI PSS GREEN VII

    Oticon

    FDA UDI
    Oticon A/S·05707131338815·SIYA 2, BTE 13 2.4G 85 C092

    LIFE SPINE INTERSPINOUS FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INVISIPORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONTOUR PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024

    CONTOUR PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·October 21, 2014

    GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 26, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 4, 2011

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 10, 2023

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 23, 2023

    BACT/ALERT MP - 419744

    FDA Adverse Event
    Malfunction ·BIOMERIEUX INC.·Product code MDB·December 5, 2019

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024