BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    OMED DISPOSABLE SCALPEL

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

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989052329·LOWER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 28

    Fluid, Hysteroscopy

    FDA Pre-Market Approval
    FDA Class 3 ·DEXTRAN HM 32%

    Cook 810 Set, Desilets-Hoffman Introducer Set

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

    ORTHODONTIC. PLASTIC BRACKET PRIMER

    FDA 510(k)
    FDA Class 2 ·Dental

    Fluid, Hysteroscopy

    FDA Pre-Market Approval
    FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

    Fluid, Hysteroscopy

    FDA Pre-Market Approval
    FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

    Fluid, Hysteroscopy

    FDA Pre-Market Approval
    FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

    Fluid, Hysteroscopy

    FDA Pre-Market Approval
    FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

    Fluid, Hysteroscopy

    FDA Pre-Market Approval
    FDA Class 3 ·DEXTRAN HM 32

    Fluid, Hysteroscopy

    FDA Pre-Market Approval
    FDA Class 3 ·DEXTRAN HM 32

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·October 13, 2010

    FORTIFY DR, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FMG·December 19, 2012

    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