BEUDAMED
    19 results · 19ms · Sources: EU EUDAMED, US FDA

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    BIONIME DIABETES MANAGEMENT SYSTEM VI.0

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Bone Curette

    FDA UDI
    ELLIQUENCE, LLC·00846338006815·

    NEO / Kinetic Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837036331·A/O Straight Handle

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130070·Rocker, One Piece

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100070·Tray Insert 1, NIDO

    Link OptiStem

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575283132·Modular stem, uncemented, Ti6Al4V, oval

    OUTLOOK

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·June 11, 2013

    BELLEGLASS HP ENAMEL 2

    FDA 510(k)
    FDA Class 2 ·Dental

    AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 17, 2014

    IMPLANT SYSTEM, MPFL

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·May 15, 2013

    PENTA

    FDA Adverse Event
    Injury ·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014

    FORCE FX-C GENERATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·May 25, 2011

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·December 18, 2013

    BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36

    FDA Recall
    Open, Classified ·BioPro, Inc.·Product code LZY·September 9, 2025

    BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36

    FDA Enforcement
    Class II ·Ongoing·BioPro, Inc.·October 22, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021