BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

    FDA 510(k)
    FDA Class 2 ·Immunology

    Symmetry Scoville-Greenwood

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482139868·Symmetry® Bipolar Forceps; Scoville-Greenwood B...

    XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TEMPHASE

    FDA 510(k)
    FDA Class 2 ·Dental

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023

    COMPLETE DOUBLE MOIST

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    DUAL LUMEN L-CATH PICC CATHETER

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES, INC.·Product code DQX·April 6, 2011

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 17, 2008

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·March 27, 2024

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 15, 2024

    BD INTIMA-II Y 22GAX1.00IN PRN/EC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 28, 2023

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·May 4, 2016

    Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·March 25, 2026

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014