BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    Voyant Open Sealer-Divider Device

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707012139·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 17

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376546070·SPS FA Self-Drill Screw, 3.5 x 17 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376695242·PROXIMITY FA SELF-DRILL SCREW, 3.5 x 17mm

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981041052·Screw - Self-Drilling - 3.5x17mm

    TRANSMITTER, ZS-940PA SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRABECULAR METAL FEMORAL CONE AUGMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VALEO / VALEO II

    FDA Adverse Event
    Malfunction ·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020

    ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·June 3, 2013

    MAXI MOVE

    FDA Adverse Event
    Injury ·ARJO MED AB LTD·Product code FSA·September 3, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·June 2, 2011

    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