BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    AVITA INFRARED THEROMETER WITH BLUETOOTH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970355·

    SAUFLON MULTI LENS CARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

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

    STEM: AMISTEM H HA COATED STD STEM SIZE 7

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2019

    ADAPTA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·May 14, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 23, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·June 1, 2011

    TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 3, 2018

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025