BEUDAMED
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    SENTINEL CHOLINESTERASE LIQUID

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Mini Telemetry System

    FDA UDI
    WIPRO GE HEALTHCARE PRIVATE LIMITED·00840682116992·

    Mini Telemetry System

    FDA UDI
    WIPRO GE HEALTHCARE PRIVATE LIMITED·00840682117081·

    Mini Telemetry System

    FDA UDI
    WIPRO GE HEALTHCARE PRIVATE LIMITED·00840682117111·

    Mini Telemetry System

    FDA UDI
    WIPRO GE HEALTHCARE PRIVATE LIMITED·00840682117173·

    STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ANSPACH EMAX DRILL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    16CM MIN. INVASIVE ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013

    TOSHIBA

    FDA Adverse Event
    Injury ·TOSHIBA MEDICAL SYSTEMS CORPORATION·Product code MQB·April 10, 2013

    NORMAL SALINE IV FLUSH, 10ML

    FDA Adverse Event
    Injury ·Product code NGT·May 16, 2008

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 12, 2011

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015

    8CM ANGLE ATTACHMENT, BLACK, MAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 9, 2014

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

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

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

    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