BEUDAMED
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    HARDYDISK GENTAMICIN, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO

    FDA 510(k)
    FDA Class 1 ·Dental

    AMERLEX-MAB FT4 KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    G7 HI-WALL E1 LINER 36MM D

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·October 30, 2024

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·March 8, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·February 16, 2011

    ADAPTA SR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014

    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