BEUDAMED
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    CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196488·AK3 Femoral Inserter/Impactor

    Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm

    FDA UDI
    Promepla·03700512966210·

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm

    Insemi-Form

    FDA UDI
    COOK INCORPORATED·00827002189034·Insemi-Form, Catheter

    PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDX 1000 SERIES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AXXENT FLEXISHIELD MINI (K090417)

    FDA Adverse Event
    Injury ·XOFT, INC.·Product code IXI·January 7, 2011

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 26, 2022

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 2, 2023

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 15, 2014

    LINOX S 65

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code LWS·May 4, 2011

    SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. 23.1:BK040048 23.2:BK080020 25.0:BK090017 The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code MMH·June 22, 2010

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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