BEUDAMED
    23 results · 35ms · Sources: EU EUDAMED, US FDA

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    ESPIRT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00887517232090·Universal Broach, 8x18mm

    Harvard Cement quick setting, Clinic powder, Shade 8

    FDA UDI
    Harvard Dental International GmbH·EHAR70012081·Zinc phosphate cement

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001208·artVeneer life upper anteriors, BIL, B2

    TruFlex™

    FDA UDI
    Ortho Organizers, Inc.·00190707126667·TRUFLEX NiTi Thermal Euro Lower 17x25 (10pk)

    Scanlan® TIP-GUARD™ instrument protectors - Clear

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159001938·Scanlan® TIP-GUARD™ instrument protectors - Ori...

    TruFlex

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730013972·NiTi Thermal Euro Lower 17x25 10 archwires per ...

    PRCT2

    FDA UDI
    FX SOLUTIONS·03701037307700·TRIAL DIAPHYSEAL PLATE 8 HOLES

    CODMAN ACP CENCELLOUS BONE SCREW

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC./MEDOS S.A.·Product code KWQ·December 21, 2001

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180506776·LIF Broach, 12MM X 8MM

    PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·May 9, 2016

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 24, 2011

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE SJ·Product code JPA·February 22, 2008

    BD PLASTIPAK 50ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 20, 2021

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    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