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

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    SPARTAN RX CYP2C19 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2025

    NA

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NLQ·May 15, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022