BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Nuvo Nano Portable Oxygen Concentrator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FORTIFY VR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 24, 2014

    NEXGEN MIS STEMMED TIBIAL COMPONENT PRECOAT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·October 28, 2010

    EGIAUSTND

    FDA Adverse Event
    Other ·COVIDIEN·Product code GDW·December 21, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014