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

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    LEMPERT OPTIC DISC ANALYSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPINE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Entasis 3D Dual-Lead Sacroiliac Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LATERAL STRAIGHT STEM 15.0 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWB·March 28, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013

    PRISM REACTION TRAYS

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·December 14, 2010

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 9, 2014

    SULOX-HD 32 M 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·April 23, 2019

    SULOX, HEAD, M¸ 32/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWB·August 3, 2018

    SULOX-HEAD 28 M 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LPH·April 4, 2019

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    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