BEUDAMED
    15 results · 31ms · Sources: EU EUDAMED, US FDA

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    LECTEC NON-INVASIVE PACING ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228720121·GC Initial™ PC Pellets Dentin C3, 5pcs. X 2

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709228·GC Initial™ PC Pellets Dentin C3, 5pcs. X 2

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376680606·Proximity Drill, 12mm

    n/a

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008723140121·Rotary diamond instrument for dental application

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867311718·Low Profile Screw, 2.0 x 12mm, Cortical

    LOW PROFILE SCREW, 2.0 X 12MM, CORTICAL

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·March 12, 2025

    VAL SCREW, TI, 2.0 X 14MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·March 12, 2025

    REFLEXION SPIRAL VARIABLE RADIUS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    star RF Electrode, VIVA RF Electrode

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010

    WASHER 13.0MM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HTN·December 13, 2012

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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