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

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    CUVIS-spine

    FDA 510(k)
    FDA Class 2 ·Neurology

    EarQ

    FDA UDI
    Oticon A/S·05707131353351·G40 S, MINIRITE 312 2.4G C063 EARQ

    FAC-4 - Duke Power Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet

    Puget Sound Energy - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal

    RESTFUL NIGHTS, IST-APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code NPT·November 20, 2024

    EEA 28MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·October 17, 2008

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·June 26, 2013

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    FDA Adverse Event
    Malfunction ·SIGMA·Product code FRN·August 8, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·February 13, 2023

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 13, 2024

    SAPIEN 3 ULTRA VALVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code NPT·August 8, 2021

    FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXC·August 7, 2013

    F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems·April 4, 2018

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012