BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KIMAX, MODEL 1024

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 19, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014

    HUDSON SHERI-I-BRONCH ENDOBROCHIAL TUBE, LS, 37F

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CBI·April 11, 2011

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020