BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Origin Coxa Vara Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517731166·CoRoent XL+, 11x18x55mm 15°

    ACIF Interbody System

    FDA UDI
    Tyber Medical, LLC·M695M2C161155S0·ACIF TYPEEK Coated 16mm x 11mm, 5 deg Straight

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694047159·PrimaLIF LLIF PEEK Implant, 11mm X 22mm X 55mm,...

    BD LOGIC BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code NBW·January 6, 2005

    VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AURADORM (NEUROMUSCULAR SLEEP)

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 4, 2017

    SIGMA 300 DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·October 10, 2014

    OT PING METER

    FDA Adverse Event
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·July 8, 2011

    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015