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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    RESORB-X RESORBABLE PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040011072·Zirlux 16+ C2 100X25

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344811·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344842·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344804·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344859·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344828·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344873·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0115100·Handle, Targeting Needle

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344835·

    NEUROPACK MICRO, MODEL MED-9100A SERIES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DND 101

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 28, 2025

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·September 12, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    SOFT TOUCH ® II

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 19, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 9, 2011

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 30, 2020

    ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022