BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    WINK-EASE PERSONAL PROTECTIVE EYEWEAR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127021428·Face Changing Liner Trial Size 62/68 x 36mm ID

    PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS

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

    speX Support Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·June 16, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 14, 2012

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 21, 2010

    TFNA HELICAL BLADE 75MM STERILE.

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·March 19, 2020

    Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 13, 2014