BEUDAMED
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    ELECTRODE JUNCTION BOX, MODEL JE-921A

    FDA 510(k)
    FDA Class 2 ·Neurology

    Neo-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043508336·

    AT WORK DRUG TEST, MODEL 9177T AWT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BOYD DELIVERY UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·January 9, 2019

    SMALL BATTERY DRIVE CASING FOR 12V BATTERY

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·April 10, 2013

    RIATA ACTIVE FIXATION LEAD

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

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011

    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