BEUDAMED
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    QUANTUM BLAST

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040007976·Zirlux 16+ A3.5 89x17x12

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450208328·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033366110·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033366066·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033366103·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033366080·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033366097·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033366073·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033366127·

    ALIEN RX MICRO CANNULA, MODEL 4530

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 3, 2013

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·May 8, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 20, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·February 14, 2011

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·July 9, 2014

    ELECTRIC DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·August 29, 2013

    DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·July 3, 2013

    Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.

    FDA Enforcement
    Class II ·Terminated·Medrad Mr Inc·January 29, 2014