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

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    SINGLES

    FDA 510(k)
    FDA Class 1 ·Dental

    COOLTOUCH ND: YAG LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EXCELSIOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 12, 2016

    NEXGEN CR-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·January 23, 2013

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·November 18, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2014

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019