BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    OPTI-TEARS(R)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989022483·PEERLESS 0DEG SGLLFM-22TRQX022 LL

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189381·AK3 Femoral Distal Locating Device, 3° Bushing

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077373·CURVED RASP

    XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AirSeal

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OT VERIO2 METER

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

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 24, 2014

    FOX PLUS PTA CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code LIT·October 22, 2010

    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