BEUDAMED
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    SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074027708·BONE SCREW 7020735 ILIAC 7.5X35 SS

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120207351·Carbide, cone flat, excavating and fissure bur

    AXIOM MEDICAL, INC.

    FDA registration
    AXIOM MEDICAL, INC.·11 products·🇺🇸 United States

    ASCENT XXL OPEN BOX FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPEEDYBELL

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

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·July 18, 2017

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·July 18, 2017

    HEMOCUE GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code LFR·May 23, 2011

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    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

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code LFR·August 18, 2014

    BARD

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (GFO)·Product code DTK·March 7, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 16, 2011