BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    CATHETER, THERMAL DILUTION FIBEROPTIC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517119759·Helix-T Plate, 34mm 1-Level

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00147811340·2G Narrow CC-314

    G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray

    FDA 510(k)
    FDA Unclassified ·Unknown

    PLASTIC FINGER CUFFS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·November 19, 2019

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 30, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 10, 2012

    SOVEREIGN SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·July 28, 2010

    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·March 29, 2017