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

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    AIA-PACK T-U

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CEMENT RESTRICTOR

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

    SONIXTABLET ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRILL F.RADIOLUCENT TARGETING DEVICE SIDEWINDER Ø3,2 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·September 16, 2013

    HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 13, 2012

    4.5MM LCP PROXIMAL FEMUR PLATE 8 HOLES/247MM-RIGHT

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·February 3, 2017

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 14, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 22, 2010

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·July 3, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021