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

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    gammaCore-S

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690194798·Tibial Punch Guide

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481121814·LOCATOR F-Tx Abutment For 6.0mmd Tri-Nex Connec...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383549608·Gutta Percha Points is used to root canal filin...

    InFill Lordotic ACF

    FDA UDI
    PINNACLE SPINE GROUP, LLC·00814729025554·

    InFill Anatomic ACF

    FDA UDI
    PINNACLE SPINE GROUP, LLC·00814729025677·

    SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018

    MICROPLEX (MCS) 10-SYSTEM COIL

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code HCG·June 21, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 22, 2008

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 14, 2014

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018