BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    GENERAL SEMEN ANALYSIS KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    REPHRESH VAGINAL GEL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 20, 2019

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 22, 2013

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 13, 2011

    WECK HEM-O-LOK ENDO5

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDO·July 9, 2008

    BD INSYTE AUTOGUARD WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 26, 2020

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024