BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    BIOPLEX 2200 EBV IGG AND SYPHILIS IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1204390·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776194703·RING STYLE RETRACTOR ST MARKS WITH LIP

    STATUS HCG SERUM/URINE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDIWORKS SLIT LAMP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TRIDENT CONSTRAINED INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWZ·May 20, 2013

    OT VERIO SYNC METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 3, 2011

    I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015