BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    OARtrac System

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    PROCARE

    FDA UDI
    DJO, LLC·00190446660385·KNEE BRACE, HINGED MED

    GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013

    BASIX COMPAK INFLATION SYRINGE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·July 11, 2011

    HALO360 ABLATION CATHETER

    FDA Adverse Event
    Other ·BARRX MEDICAL, INCORPORATED·Product code GEI·September 19, 2008

    MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·October 24, 2019

    WILSON-COOK ACHALASIA BALLOON

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code PID·June 17, 2021

    MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·January 10, 2020

    CPX4 PLUS SMOOTH TALL HEIGHT 550CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·April 19, 2022

    WILSON-COOK ACHALASIA BALLOON

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code PID·October 6, 2020

    CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 22, 2021

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

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