BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    AS 30/TCP MODULE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO REMSTAR AUTO CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·November 14, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 10, 2010

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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