BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    NEOSS ACCESS ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    ComfortGel Blue

    FDA UDI
    Respironics, Inc.·00606959043923·ComfortGel Blue Full Mask w/SE, Medium, JP

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Other ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·October 26, 2009

    AVALIGN

    FDA Adverse Event
    Malfunction ·AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code HAE·June 17, 2019

    MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIGITAL CLINICAL THERMOMETER, MODEL KD-193

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·July 21, 2009

    SYNCHRON LX®20 PRO SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·April 29, 2013

    CARPENTIER-EDWARDS BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·July 22, 2008

    CAMTEC

    FDA Adverse Event
    Malfunction ·CAMTEC·Product code FNL·May 3, 2011

    RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code NIM·October 1, 2009

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024