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

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    Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131376268·OPN S 1, MINIRITE T 312 2.4G C094

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)

    XTRACT SYRINGE KEY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAAS II QVA

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    ONE TOUCH BASIC

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·August 23, 2005

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026