BEUDAMED
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    da Vinci Surgical System (IS5000)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517570871·CoRoent Ant TLIF Ti, 14x11x28mm 4°

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704265682·

    LCP

    FDA UDI
    Synthes GmbH·10886982166555·3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 5 HOLES-...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694022958·FPS 2.7mm 1st MTP/MPJ Plate Large Right

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694077484·FPS 2.7 1st MTP Large Right Plate Sterile Qty 2

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·June 29, 2020

    CASPIAN SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDICULT IVM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BD POSIFLUSH

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·January 3, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 20, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014