BEUDAMED
    8 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.

    DRAWER TEST

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581271300001·A-FIT® 2. MOLAR UPR LFT SZ 13

    Scoreflex PTA Scoring Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 15, 2014

    ATTAIN

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·October 31, 2012

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 16, 2010

    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