BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    7D Surgical Hex Screwdriver (4mm Nut Driver)

    FDA UDI
    7D Surgical ULC·00628341520867·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100070·Tray Insert 1, NIDO

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197024839·Braithwaite Skin Graft Knife,left handed 325mm,...

    POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CALGAESEAL MODEL: CAS

    FDA 510(k)
    FDA Unclassified ·Unknown

    PALAXPRESS, CLEAR, 1000G POWDER

    FDA Adverse Event
    Injury ·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·May 13, 2013

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 23, 2014

    50MM LFT STANDARD OFF

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·June 1, 2011

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018

    Video Cystoscope models ECY-1570 and ECY-1570K

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·February 21, 2018

    IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·May 16, 2018

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024