BEUDAMED
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    SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Diversatek Healthcare

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·M7831217140·Gastric Sump Tube, 14 French

    GRIPTION

    FDA UDI
    DEPUY (IRELAND)·10603295381303·GRIPTION TF SCREW 5.5mm x 14mm

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS

    FDA 510(k)
    FDA Class 2 ·Dental

    RT-PLUS PE INSERT CLAMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 13, 2014

    SYSTEM 2000

    FDA Adverse Event
    Malfunction ·ARJO HOSP EQUIPMENT AB·Product code ILJ·May 9, 2013

    SEEDNET ICEROD 90 DEGREE NEEDLE

    FDA Adverse Event
    Malfunction ·GALIL MEDICAL LTD.·Product code GEH·May 18, 2011

    ARCHITECT B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025

    ACCESS ACCUTNI REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·September 22, 2025

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024