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    POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Round bar with rider

    FDA UDI
    Cendres+Métaux SA·07640166513797·Round bar with rider Female part E

    ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094

    FDA 510(k)
    FDA Class 1 ·Hematology

    SYNTHES (USA) IMF SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    STONYBROOK HSP NY NY 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015

    9900

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

    FLAIR ENDOVASCULAR STENT GRAFT

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code MIH·March 15, 2011

    TENDRIL ST

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

    KYPHON KURVE BONE FILLER DEVICE 13GA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

    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