BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    NeuMoDx GBS Assay

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Dandy Clear Aligners

    FDA UDI
    Orthly, Inc.·00860006891206·

    VIRTUOST

    FDA 510(k)
    FDA Class 2 ·Radiology

    FASTPACK CONTROL KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EXTRACTOR HANDLE OMEGA2 HANSSON TWIN HOOK

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·June 1, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 15, 2014

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·June 17, 2013

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011

    SUREFORM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code GDW·July 28, 2020

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024