BEUDAMED
    9 results · 27ms · 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.

    4 SURE TM ENTERAL FEEDING BAG

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

    Alpine SL

    FDA UDI
    Rmo, Inc.·00885797695284·ROTH ALPINE SL 022 HK/345 5-5 20 EA

    DISPOSABLE PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LPP (LOW PROFILE PORT)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRIDENT 0° CROSSFIRE INSERT 28 MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·June 23, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    ASR ACETABULAR IMPLANT 62

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 18, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 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