BEUDAMED
    23 results · 27ms · Sources: EU EUDAMED, US FDA

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    TRIPLE LUMEN PFM PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649514·INTREPED 09x14 implant

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100140·Implant Tray, Cosmolock, Arcamed

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K1190140·Tray Insert 6, Cosmo MIS,Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100140·Implant Tray

    BEAUTIFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDLINE EPIDURAL AND SPINAL NEEDLES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·April 20, 2015

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN (IRVINE)·Product code OUT·April 8, 2015

    UNK BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code MJN·February 11, 2022

    VUE PACS

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 23, 2014

    ENDOPROBE, 23G STRAIGHT

    FDA Adverse Event
    Malfunction ·IRIDEX CORP.·Product code GEX·April 1, 2011

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·May 29, 2012

    INFANT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 27, 2012

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Death ·COVIDIEN (IRVINE)·Product code OUT·April 21, 2015

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 27, 2012

    UNK BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code MJN·February 11, 2022

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024