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

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    ENSEAL PTC TISSUE SEALING DEVICE

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

    POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 24, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 25, 2024

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 22, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·September 9, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 27, 2011

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GCB·September 30, 2020

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GCB·September 30, 2020

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GCB·September 17, 2020

    Cook

    FDA UDI
    COOK INCORPORATED·00827002101005·Yueh Centesis Disposable Catheter Needle

    Cook

    FDA UDI
    COOK INCORPORATED·00827002104747·Yueh Centesis Disposable Catheter Needle

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GCB·March 27, 2023

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GCB·October 28, 2020

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GCB·May 19, 2017

    YUEH CENTESIS CATHETER NEEDLE

    FDA Adverse Event
    Injury ·COOK INC·Product code GBO·September 1, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017