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

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    ZSFab Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551313695·Irrigation Tube, 100K

    90° CONTRA ANGLE DRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·August 29, 2018

    90° CONTRA ANGLE DRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·August 29, 2018

    90° CONTRA ANGLE DRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·August 29, 2018

    90° CONTRA ANGLE DRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·August 29, 2018

    Vu ePOD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981048808·26mm Trial, 5 Deg, 10 mm

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011252610200·ceraMotion® Me 3D Dentin CC3-1, 20 g / dental c...

    IMAGE STAR II

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ventrax Delivery System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Exactech, Inc.·10885862552174·TRIAL, TIBIAL SPACER, SIZE 0, 10 mm

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

    IVT DISPOSABLES

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 15, 2013

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 24, 2025

    90° CONTRA ANGLE DRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·August 8, 2018

    90° CONTRA ANGLE DRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·August 8, 2018

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014