BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    LIFELINES PHOTIC STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    Zethon

    FDA UDI
    ZETHON LIMITED·05059358049792·STERILE IRRIGATION TUBE KIT - D SHANK

    Luxe™ 2.5 Semi-custom loupe

    FDA UDI
    METREX RESEARCH, LLC·00850036373599·Semi-custom loupe with Luxe™ 2.5 plano oculars,...

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434571·Tasso+ convenience kit allows self-collection o...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383554367·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502177·Gutta Percha Points is used to root canal filin...

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471133873·T D-Form 017X027

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00840326426173·NiTi Thermal Archwire, D-Form .017x.027 10EA

    KIMSTIM AURICULAR ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·August 26, 2024

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWS·July 23, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 11, 2011

    ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code LIT·August 7, 2008

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020