BEUDAMED
    7 results · 17ms · 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.

    VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM

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

    MODEL 366-13 ADAPTAID STEP DOWN ADAPTER

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DE-TOX TUBES A AND DE-TOX TUBES B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·June 19, 2014

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 15, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·January 19, 2011

    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