BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    CELLTRACKS ANALYER II

    FDA 510(k)
    FDA Class 2 ·Immunology

    Plateau-C Ti

    FDA UDI
    Life Spine, Inc.·00190837066611·Cervical Rasp, 7°, 6mm x 16mm x13mm

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020

    MEDI-SIS SYRINGE INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLADIATOR¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 6, 2012

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 9, 2013

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·May 20, 2011

    UNKNOWN PRODUCT - HIP IMPLANT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·August 12, 2008

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

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

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

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021