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

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    AURAFLEX SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Site-Rite 6 Ultrasound System with Pinpoint GT Technology

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GLENOSPHERE CENTRIC 36 MM DIAMETER +0 MM LATERAL OFFSET

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·December 6, 2021

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 4, 2013

    AVON PAT/FEM JOINT EX SMALL

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code KRR·December 22, 2010

    2.3MM X 18MM LOCKING CORTICAL SCREW

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·July 17, 2014

    36MM VIT E LINER +0MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·December 6, 2021

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025