BEUDAMED
    17 results · 39ms · Sources: EU EUDAMED, US FDA

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    Nox Sleep System

    FDA 510(k)
    FDA Class 2 ·Neurology

    GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    O-SCAN MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH

    FDA Adverse Event
    Malfunction ·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023

    PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017

    PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 13, 2017

    BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 18, 2016

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 22, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 27, 2013

    ASR ACETABULAR CUPS 62

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 15, 2011

    BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018