BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA

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

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925016507·PISTON WITH ARMSTRONG PLATINUM RIBBON LOOP .6 M...

    CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 13, 2018

    AXSYM CYCLOSPORINE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOPRO POLAR HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 24, 2022

    CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 8, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 3, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 31, 2013

    SECURE ACUTE CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 15, 2011

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    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