BEUDAMED
    8 results · 19ms · 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 ×

    MINIFIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GAMBRO FLUID CONTROL MONITOR FCM 10-1

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

    C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE

    FDA 510(k)
    FDA Class 1 ·Dental

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 29, 2024

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

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

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FPA·January 11, 2011

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 5, 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