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

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    A.B. DENTAL DEVICES Dental Implants System

    FDA 510(k)
    FDA Class 2 ·Dental

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741824550·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674182455060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1824550·18mm H x 24mm W x 55mm L x 0 degrees XLIF

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704513301·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X182455120·18mm H x 24mm W x 55mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X18245580·18mm H x 24mm W x 55mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L182455120·18mm H x 24mm W x 55mm L XLIF Trial 12 degree L...

    AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HEARTSTART MRX-EMS DEFBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    8MM MCS TIP COVER ACCESSORY

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 28, 2011

    AC GRAFT ROPE, STERILE

    FDA Adverse Event
    Other ·ARTHREX INC.·Product code HTN·September 12, 2008

    SELDRILL-SCHANZSCR Ø5 L200/80 SST

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    SELDRILL-SCHANZSCR Ø5 L200/80 SST

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 17, 2017

    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