BEUDAMED
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    Disposable Pressure Transducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284331·BECKMAN RETRACTOR 12 1/4" 4X4 BLUNT

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704920829·

    VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEPUY GLOBAL SHOULDER CROSSLINK GLENOID

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 11, 2025

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 10, 2025

    EX-PRESS MINI GLAUCOMA SHUNT

    FDA Adverse Event
    Malfunction ·OPTONOL, LTD·Product code KYF·October 6, 2014

    CAPSURE Z NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code DTB·June 7, 2013

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 28, 2011

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018