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

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    ERBE VIO ESU, MODEL VIO 200 S

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

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025

    ENVOY AND VISTA BRITE TIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AL-40

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

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    HEDSTROEM FILE

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EKS·April 9, 2013

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·July 18, 2008

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·May 6, 2011

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 19, 2025

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 22, 2025

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020