BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    B-Secur HeartKey Software Library

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694094580·ICON Plating System, 2-Bay

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694094610·Front Cover Plate, ICON 2-Bay

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694094603·Auxiliary Tray, ICON 2-Bay

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694094627·Lid, ICON 2-Bay

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 29, 2022

    POSIFLUSH

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026

    BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EXCELLITE LIGHT CURE UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    POSIFLUSH

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026

    BD POSIFLUSH

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026

    BD POSIFLUSH

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026

    POSIFLUSH

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 30, 2011

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·July 2, 2013

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016