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

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    OFNat Lubricant (L15)

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

    BD LUER-LOK¿ SYRINGE STERILE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·February 24, 2023

    ILT TORQUER, MODEL 114TR1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·January 19, 2026

    BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE - X100L

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·November 16, 2022

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 5, 2008

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code HIH·August 16, 2011

    LIFECEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 26, 2013

    SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024