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

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    Bridge Occlusion Balloon

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707015222·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 30

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100301·INFANT WIRE SPECULUM 3MM/5MM BLADES

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

    SPIRODOC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

    CAPSURE SP

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    FREESTYLE PRECISION NEO H

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    DYB INTRODUCER, CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·November 12, 2025

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 15, 2020

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code ELC·April 29, 2020

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code ELC·May 31, 2023

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·February 7, 2020

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 18, 2015

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023