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    QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Logical 20° Hooded Liner

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215095246·

    SYNTHES ANTERIOR CSLP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 19, 2018

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·March 7, 2013

    TENDRIL SDX

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

    HEARTSTART MRX - EMS DEFIBRILLATOR

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

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54, 48, CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 28, 2019

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·February 20, 2018

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·February 20, 2018

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ 40, CODE F

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 13, 2018

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 62/56, CODE V

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·January 31, 2018

    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