BEUDAMED
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    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011845027000·dentaform® Bands Central Upper right No. 27

    COLOTRAK OCCULT BLOOD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    OPERATING ROOM STAND

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

    STANDARD INSERTION HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·June 3, 2014

    NOVAMAX LINK GLUCOSE MONITOR

    FDA Adverse Event
    Other ·NOVA BIOMEDICAL CORP.·Product code NBW·November 8, 2012

    TRIP LUM CATH KITS 16CM X 5

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MPB·September 8, 2010

    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