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

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    ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Leksell Vantage Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201501283·FirmFix™ 2

    23GA Illuminating Laser Probe, SMA906

    FDA UDI
    Peregrine Surgical, Llc·00632307001819·23GA Illuminating Laser Probe, SMA906

    Hepatitis A Test (Antibody And Igm Antibody)

    FDA Pre-Market Approval
    FDA Class 2 ·ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS

    Multicare Platinum

    FDA UDI
    Hologic, Inc.·15420045505926·

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710820400170·Zadik Calcaneal Guide, 40mm x 17°

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310400170·Talar Osteotmy Guide, 40mm x 17mm

    H-SCRIBE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 14, 2023

    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 20, 2025

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·April 8, 2013

    U BY KOTEX CLICK TAMPONS

    FDA Adverse Event
    Malfunction ·AVENT S. DE R.L. DE C.V.·Product code HEB·March 9, 2011

    EASY LOAD INSERTION DEVICE

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code MSS·May 6, 2008

    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OJA·June 5, 2025

    BD ONCLARITY HPV ASSAY REAGENT PACK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MAQ·September 12, 2024

    BD ONCLARITY HPV ASSAY REAGENT PACK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MAQ·September 12, 2024

    BD ONCLARITY HPV ASSAY REAGENT PACK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MAQ·September 12, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024