BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    FACTS MONOBLOCK

    FDA 510(k)
    FDA Class 2 ·Radiology

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981267·anteriors; shade C1; mould UM4

    Symmetry Mixter

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482087428·Symmetry® Dissector, Mixter, Standard Handle w/...

    BIOTROL CK MONOEACTIF

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HYGEIA-5 OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOPATH DILATING TIP TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GCJ·March 20, 1998

    ENDOPATH DILATING TIP TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GCJ·March 20, 1998

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·February 27, 2013

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    POPULAR PLASTICS·Product code IKX·August 5, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·February 2, 2011

    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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020