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

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    CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001213·artVeneer life upper anteriors, IM, B2

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00121031·

    TruFlex

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730014016·NiTi Thermal Euro Lower 20x20 10 archwires per ...

    Alpine

    FDA UDI
    Ortho Development Corporation·00822409000425·Alpine Cemented Stem 13 EXT

    SCANLAN® Endoscopic TIP-GUARD™ instrument protectors - Clear

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159001976·SCANLAN® Endoscopic TIP-GUARD™ instrument prote...

    TruFlex™

    FDA UDI
    Ortho Organizers, Inc.·00190707126704·TRUFLEX NiTi Thermal Euro Lower 20x20 (10pk)

    MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Neurology

    JELDENT BASIC LINE

    FDA 510(k)
    FDA Class 2 ·Dental

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 8, 2011

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 8, 2013

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·February 24, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008

    ON-Q PAIN PUMP

    FDA Adverse Event
    Injury ·I-FLOW, LLC.·Product code MEB·January 17, 2014

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

    INTACS CORNEAL IMPLANTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

    CRANIOFACIAL RIGID FIXATION SYSTEM

    FDA Adverse Event
    Injury ·OSTEOMED·Product code MQN·November 7, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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