BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    MEDVISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bosworth

    FDA UDI
    Keystone Industries·H66809214841·WONDER WEDGES (100) Assorted Colors, sizes

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123809·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 100mm

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150591·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 200mm

    HEMOGLOBIN A1C CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENSITE CLASSIC SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 21, 2014

    KAPPA 700 DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·December 13, 2010

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·January 10, 2013

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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