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

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    Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece

    FDA 510(k)
    FDA Class 2 ·Neurology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613018009·K-Wire, Single Ended, Trocar Point, Diameter Si...

    NAIL HOLDING SCRE WGAMMA3 8X35MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012

    FLEX ENDOSCOPIC INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·September 9, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 10, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 22, 2013

    HELICAL BLADE INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·April 18, 2017

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014