BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    IRON REAGENTS ITEM NUMBER: SR1017

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189374·AK3 Femoral Distal Locating Device, 4° Bushing

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989022490·PEERLESS 0DEG SGLLFM-22TRQX018 LL

    Kingon P2 Oxygen Concentrator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WAVEON WRX BONE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

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

    ATLAS PLUS DR

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