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

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    Electronic Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HTF-HEPES

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

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWR·April 7, 2010

    COCR HEAD 28/+4 'L' 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 2, 2009

    RESTORE ADVNACED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 30, 2010

    VACUETTE SAFETY BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE·Product code FMI·June 12, 2013

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 11, 2011

    SINGLE USE 3-LUMEN SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDR·September 16, 2014

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·November 25, 2009

    PROSTHESIS, RIB REPLACEMENT

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MDI·May 31, 2019

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·September 4, 2009

    PROSTHESIS, RIB REPLACEMENT

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MDI·May 31, 2019

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021