BEUDAMED
    28 results · 25ms · Sources: EU EUDAMED, US FDA

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    PTS PANELS MULTI-CHEMISTRY CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ONESTEP

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 27, 2026

    Affinity™ Inflex RS 120ml 2-Pack

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883001933·VPS Impression Material

    Affinity ™ Inflex RS 120ml 2pk

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012379·VPS Impression Material

    SteriLance OneStep

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·16945630123488·

    STERiLANCE OneStep Lancing Device

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·06945630135309·

    ONESTEP

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 27, 2026

    ONESTEP

    FDA Adverse Event
    Malfunction ·BIO-DETEK INCORPORATED·Product code MKJ·February 27, 2020

    ONESTEP

    FDA UDI
    Zoll Medical Corporation·00847946016272·ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

    Phonak

    FDA UDI
    Sonova AG·07613275553138·Phonak Virto B70-312

    SYNTHES CALCANEAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    8900-0224-01

    FDA Adverse Event
    Malfunction ·BIO-DETEK INCORPORATED·Product code MKJ·May 6, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    ONESTEP

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LIX·August 24, 2023

    ONESTEP

    FDA Adverse Event
    Injury ·ZOLL MEDICAL CORPORATION·Product code LIX·March 14, 2025

    ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

    FDA Adverse Event
    Malfunction ·BIO-DETEK INCORPORATED·Product code MKJ·July 9, 2025

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 22, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 17, 2011

    EMBRACE PUMP

    FDA Adverse Event
    Malfunction ·Product code LZH·March 26, 2008