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

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    ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    StatStrip Xpress 2 Glucose Hospital Meter System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·June 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 10, 2012

    UNKNOWN OPTEASE VENA CAVA FILTER

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code DTK·June 23, 2015

    METRX II

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·November 27, 2023

    S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD

    FDA Enforcement
    Class II ·Ongoing·Stryker Communications·March 31, 2021

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026