BEUDAMED
    3,396 results · 16ms · Sources: EU EUDAMED, US FDA

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    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·March 9, 2015

    ALERE ORATECT

    FDA Adverse Event
    Injury ·AMEDITECH, INC.·Product code DJC·October 12, 2017

    ALERE ORATECT

    FDA Adverse Event
    Injury ·AMEDITECH, INC.·Product code DJC·October 2, 2018

    CHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM

    FDA Adverse Event
    Injury ·AMERITOX·Product code DJC·May 21, 2018

    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 28, 2018

    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 28, 2018

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LIX·January 29, 2018

    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LIX·January 29, 2018

    Thin Layer Chromatography, Methamphetamine

    FDA classification
    FDA Class 2 ·Thin Layer Chromatography, Methamphetamine

    AventaMed DAC

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

    Biovotec DAC

    Manufacturer
    🇮🇪 Ireland

    OrthoXel DAC

    Manufacturer
    🇮🇪 Ireland·776 Basic UDI-DIs·786 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    DDC Dolphin Ltd.

    Manufacturer
    1 Basic UDI-DI·11 Devices

    DBC Global Oy

    Manufacturer
    🇫🇮 Finland·12 Basic UDI-DIs·12 Devices

    Euik Seok Yoo / Wellis Co, ltd

    Manufacturer
    🇰🇷 South Korea