BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Reia pessary

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

    SYSMEX POCH-100I

    FDA 510(k)
    FDA Class 2 ·Hematology

    ULTRASOUND SCANNER FLEX FOCUS 1202

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMP TM 4.7MM MTX FULL, 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 29, 2021

    IMP TM 3.7MM MTX FULL,11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 29, 2021

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    BD SAFETYGLIDE¿ INSULIN SYRINGE 30GX8MM

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·September 20, 2017

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 19, 2011

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 6, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 18, 2013

    IMP TM 3.7MM MTX FULL,11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·August 6, 2021

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025