BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MARK V DUPLEX ULTRASONIC SCAN SYS.

    FDA 510(k)
    FDA Class 2 ·Radiology

    Synthetic Polyisoprene Lubricated Male Condom - 5 senses

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 18, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·October 20, 2010

    4.0MM OSTEOPENIA SCREWS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HWC·December 20, 2012

    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 4, 2013

    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 1, 2021

    TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 12, 2014

    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021