BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    INSPIRATION VENTILATOR SYSTEM 5I/7I

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ArgenZ ST 98x18 ML OM3B

    FDA UDI
    ARGEN CORPORATION, THE·D818130178·Dental porcelain/ceramic restoration kit

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925013568·ANTOLI CANDELA SMALL WINDOW CURETTE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450232255·

    Tecno

    FDA UDI
    TECNO INSTRUMENTS (PVT) LTD·08964003293499·Two-Prong Hook

    Realstar Surgical

    FDA UDI
    REAL STAR SURGICAL INSTRUMENTS·00850071684209·Two-Prong Hook

    REAMER SHAFT, MOD, TRINKLE 8.0X284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWE·February 13, 2012

    ESTELITE COLOR

    FDA 510(k)
    FDA Class 2 ·Dental

    CALCIGEN PSI BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERPACK

    FDA Adverse Event
    Malfunction ·ICC-NEXERGY·Product code IYN·September 3, 2013

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014

    SPEED SCREW 5.5 IMPLANT PROCEDURE SET

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code MBI·May 22, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 18, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015