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

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    ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    COPRANCOLOR

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOBUCK CEMENT RESTRICTOR

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

    BMT TIB TRAY 67MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 14, 2021

    G7 PPS LTD ACET SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·September 12, 2018

    NEUTRAL ARCOM XL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·September 12, 2018

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 22, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·December 9, 2010

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 9, 2014

    COCR MODULAR HEADS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 12, 2018

    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