BEUDAMED
    19 results · 27ms · Sources: EU EUDAMED, US FDA

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    A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCUTRAC

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FDR IMAGE STITCHING OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014

    EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014

    PARIETEX UGYTEX PP 15X10CM X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·April 10, 2013

    PERMANENT CAUTERY HOOK INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 2, 2011

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 13, 2008

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·July 9, 2022

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018