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

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    Filters Regulation: Us FDA ×

    Custom Stable Rigid Gas Permeable Scleral Contact Lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    QUANTA FLASH CENTROMERE

    FDA 510(k)
    FDA Class 2 ·Immunology

    DAYLITE XENON LIGHT SOURCES

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    ACCU-CHEK ® ADVANTAGE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 30, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

    FDA Adverse Event
    Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019