BEUDAMED
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    HELENA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433125·Integra® Jarit® Knife Handle No. 7, 6-1/2", Hol...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450862797·

    APEXNRG RIDER

    FDA 510(k)
    FDA Unclassified ·Unknown

    VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A·Product code GFA·September 11, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·May 19, 2011

    PEDIASAT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 26, 2025

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025