BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101186·GILL CORNEAL KNIFE CURVED

    UNITOX BOTOX SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VISORB SWIFT

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

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013

    PGW .018 SV SHORT

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code DQX·December 14, 2010

    LIGAMAX CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 9, 2014

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    BD FACSCALIBUR FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012