BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    DIALYIS START CARE KIT

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    ZIP'R4/ ZIP'R4 XTRA SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 9, 2014

    CRYSTALENS ACCOMODATING IOL

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·October 19, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 28, 2015

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022