BEUDAMED
    22 results · 29ms · Sources: EU EUDAMED, US FDA

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    LUXACORE/LUXACORE DUAL

    FDA 510(k)
    FDA Class 2 ·Dental

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056080·Zirlux Multi Anterior A1,98.5X10

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00031568091827·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024021·Paddle Shaver, 7mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00024021091823·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103070·Shaver, Closed, 7mm

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0123000·Recovery Tube, MIS

    RHS HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·March 20, 2013

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·March 9, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·February 13, 2008

    CADD® EXTENSION SETS

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FPA·February 6, 2017

    CADD® EXTENSION SETS

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FPA·February 6, 2017

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 10, 2017

    UNK - NAILS: FEMORAL

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 26, 2020

    CADD EXTENSION SETS

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·March 21, 2022

    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022