BEUDAMED
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    GENIUS¿ DIGITAL DIAGNOSTICS SYSTEM

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC.·Product code QYV·April 28, 2026

    GENIUS DIGITAL DIAGNOSTICS SYSTEM

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC.·Product code QYV·May 26, 2026

    GENIUS REVIEW STATION MONITOR

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC.·Product code QYV·April 6, 2026

    Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code QYV·March 23, 2026

    Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

    FDA classification
    FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

    Lyv Healthcare

    Manufacturer
    🇫🇷 France·1 Basic UDI-DI·2 Devices

    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 19, 2025

    Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 19, 2025

    Lyv Life Inc.

    FDA registration
    Lyv Life Inc.·6 products·🇺🇸 United States

    Lyv Endo®

    Device
    EU MDR · Eu Md Class 1 ·Lyv Healthcare·No longer on the market

    Lyv Endo®

    Device
    EU MDR · Eu Md Class 1 ·Lyv Healthcare·On the market

    1MED

    FDA UDI
    Qyk Brands LLC·00850039859465·1MED Surgical Mask, Level 2, Earloop style non-...

    1MED

    FDA UDI
    Qyk Brands LLC·10850027748846·1MED Disposable Surgical Gown, Large, sterile

    1MED

    FDA UDI
    Qyk Brands LLC·00850039859502·1MED Surgical Mask, Level 1, Earloop style non-...

    1MED

    FDA UDI
    Qyk Brands LLC·00850039859472·1MED Surgical Mask, Level 3, Earloop style non-...

    QG-40

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971013897·QGV-40 Q-VISION GEN 40KW 1 PHASE

    Aria Hybrid Valve

    FDA UDI
    CYPRESS ADAPTIVE, LLC·00850013242085·Aria Hybrid valve auto expulsion suction valve ...

    LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)

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

    LiNA CystoVu™ HD

    FDA UDI
    Lina Medical ApS·05708265013968·LiNA CystoVu™ HD, Single-use Flexible Cystoscop...

    LiNA CystoVu™ HD

    FDA UDI
    Lina Medical ApS·05708265013944·LiNA CystoVu™ HD, Single-use Flexible Cystoscop...