BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    BICARBONATE TEST ITEM NUMBER: SR1006

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189367·AK3 Femoral Distal Locating Device, 5° Bushing

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989022506·PEERLESS 0DEG SGLLFM-27TRQX022 LL

    ELECTRODES, FERRIS ECG, TYPES 905,906

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Additive Cap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 5, 2015

    SENSIA SR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·November 3, 2010

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024