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

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    REFLOTRON(R) AST (GOT)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228702461·GC Initial™ MC Chroma Shade Translucent CST-M, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556703530·GC Initial™ MC Chroma Shade Translucent CST-M, 20g

    Patterson

    FDA UDI
    PATTERSON DENTAL SUPPLY, INC.·D6620708702461·FILE, PULP CANAL, ENDODONTIC

    DRIVE SHAFT FOR RIA 2 520MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·July 15, 2021

    DRIVE SHAFT FOR RIA 2 520MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRX·August 5, 2020

    ISOLATED EEG AMPLIFIER MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    DOWN PAK

    FDA 510(k)
    FDA Class 1 ·Dental

    DRIVE SHAFT FOR RIA 2 520MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRX·June 25, 2021

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 12, 2014

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 1, 2010

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 12, 2012

    DRIVE SHAFT FOR RIA 2 520MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·November 29, 2021

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024