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    CPAP HUMIDIFIER, MODEL HC238JHU

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065715·INTRAORAL ELASTICS 4,5 oz 5/16" blue

    Neo-Tee T-Piece Resuscitator Circuit

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043509043·

    PENADAPT 10

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PALAMED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·April 10, 2013

    OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

    FDA Adverse Event
    Other ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code FDF·March 31, 2011

    RIATA ST OPTIM ACTIVE FIXATION

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

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·February 23, 2010

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Injury ·SALT LAKE CITY·Product code DQX·February 23, 2010

    TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DKJ--·December 5, 2003

    Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices

    FDA Enforcement
    Class II ·Terminated·Mercury Enterprises, Inc. dba Mercury Medical·January 20, 2016