BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    3M ANTI-DSDNA FAST TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    FORCEPS CEV405 FENESTRATED 350MM JOHANN [MXI/XOM]

    FDA Adverse Event
    Injury ·XOMED MICROFRANCE MFG·Product code GEI·March 19, 2014

    INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNIGUIDE SURGICAL

    FDA Adverse Event
    Malfunction ·OMNIGUIDE SURGICAL·Product code GEX·June 27, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 12, 2010

    PINNACLE MTL INS NEUT40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 14, 2013

    PIPELINE

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 12, 2023

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 13, 2023

    smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080; 3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090; 4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070; 5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080; 6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090; 7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070; 8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080; 9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090; 10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070; 11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080; 12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 18, 2024