BEUDAMED
    12 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 ×

    BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE

    FDA 510(k)
    FDA Class 2 ·Neurology

    LA Repl. Cvr. (1Hr) 10-Pk

    FDA UDI
    SYNERON MEDICAL LTD·37290109950342·LA Repl. Cvr. (1Hr) 10-Pk, VelaShape II

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704294057·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771050121·Steinmann Pins, Double diamond, threaded, 5/32-...

    HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFICATION TO PROVIDENT HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·April 22, 2013

    MEDCARE STAND-N-WEIGHT

    FDA Adverse Event
    Other ·MEDCARE PRODUCTS, INC.·Product code FNG·May 6, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·April 19, 2011

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    Zeiss brand IOLMaster 500, Model 500, 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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015