BEUDAMED
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    DIDECO ELECTA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717108631·Midway Select Impression Material

    DATEX-OHMEDA NETWORK AND CENTRAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·March 26, 2013

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·March 16, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016