BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    ARTHROSCOPIC ENERGY SYSTEM

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

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197055697·Edna (Lorna) Towel Forceps 130mm, 5"

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197055680·Edna (Lorna) Towel Forceps 100mm, 4"

    ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM

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

    AEQ REVERSED II GLENOID SPHERE D.42MM CENTER D 25MMBASEPLATE

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code PHX·October 2, 2024

    GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    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

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·May 31, 2013

    ACCENT DR RF PACEMAKER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·October 9, 2015

    AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026