BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257128817·15-20 MV FOR MEN CLSC EW STD GREY IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257127711·15-20 MV FOR MEN SEL EW CLF STD GREY IV

    WMT MODULAR ULNAR HEAD IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RADICAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·April 16, 2015

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code KDI·April 3, 2013

    INTEGRIS ALLURA 15-12 (MONO)

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·February 15, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2008

    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

    FDA Enforcement
    Class II ·Ongoing·Quest International, Inc.·September 17, 2025