BEUDAMED
    8 results · 28ms · 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.
    Filters Regulation: Us FDA ×

    ACE OPEN-BACK HALO RING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHRON (R) SYSTEMS CREATININE REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CGX·July 2, 2011

    LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STRYKER ARTHROSCOPIC INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 15, 2013

    CYSTO/BLADDER IRRIGATION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code LJH·December 4, 2010

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 4, 2014

    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