BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    MAGNETOM Free.Max; MAGNETOM Free.Star

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523157457·Tesera-k ALIF, 31W X 26D, 17mm, 17° Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151639·Tesera-k SA, 31mm X 26mm X 17mm, 17° Lordosis, T3

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523156702·Tesera-k ALIF, 31W X 26D, 17mm, 17° Trial

    COLONGLIDE(R) LUBRICANT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 6, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 16, 2011

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM ANTERIOR

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·July 12, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024