BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Endodontic Hand Instruments

    FDA UDI
    TULSA DENTAL PRODUCTS LLC·D71668610251·Senseus Flexofile Size 010 25mm

    SWANSON

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420190093·

    ACCUTECH ENDOLITE PROBE

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

    priti multidisc ZrO2 High Translucent

    FDA 510(k)
    FDA Class 2 ·Dental

    PLMA DVC V11.51 1 N

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 14, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·December 3, 2012

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012