BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    PHANTOM XL INSULATED DILATORS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Embla

    FDA UDI
    S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD·07290013817174·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003650·Long TR BSSO Plate

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828149778·GEN4 INTERACTIVE

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981193522·Interbody, 11mm x 40mm x 8mm, 8 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981208639·Trial, 11mm x 40mm x 8mm, 8 deg

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981201517·Interbody, 11mm x 40mm x 8mm, 8 deg

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425498734·AIRTEX TWL W/3/4" FENESTRATION

    MCOMPASS ANORECTAL MANOMETRY SYSTEM

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

    DEFENDO Y-OPSY IRRIGATOR

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

    HAHN TAPERED IMPLANT Ø5.0 X 16 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 21, 2024

    HEARTMATE 3 VAD MODULAR CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·January 28, 2022

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 29, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·June 25, 2011

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOB·May 2, 2018

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013