BEUDAMED
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    POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10080196983902·HYPERINFLATION SYSTEM

    Implant-One

    FDA UDI
    Implant Logistics, Inc.·D762APT0505300·Abutment, 500 Series Angled Post .5mm Cuff Heig...

    BELLEGLASS HP ENAMEL

    FDA 510(k)
    FDA Class 2 ·Dental

    GEO STRUCTURE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Widex

    FDA UDI
    Widex A/S·05706069687118·Widex EVOKE E-IM (Clay brown ) 330, Left

    Widex

    FDA UDI
    Widex A/S·05706069687125·Widex EVOKE E-IM (Dark brown ) 330, Left

    Widex

    FDA UDI
    Widex A/S·05706069687101·Widex EVOKE E-IM (Light beige ) 330, Left

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·May 5, 2008

    ITRAK 3500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS(SLC)·Product code LLZ·April 8, 2013

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 5, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    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