BEUDAMED
    7 results · 18ms · 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.

    FLO-PHORESIS - DESENSITIZER

    FDA 510(k)
    FDA Class 1 ·Dental

    ARM-A-VIAL LV SODIUM CHLORIDE INHALAT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SHAVE PREP KITS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 3, 2014

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 17, 2008

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·November 26, 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