BEUDAMED
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    EL-RF/3 (IGM-IGG-IGA) KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150751·K-WIRE - SINGLE TROCAR 1.25mm DIA x 200mm

    PASS LP SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GC FUSION

    FDA 510(k)
    FDA Class 2 ·Dental

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·April 16, 2014

    COVIDIEN

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FZP·January 29, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 29, 2010

    Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

    FDA Enforcement
    Class II ·Ongoing·Mirion Technologies (Capintec), Inc.·June 5, 2024

    Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

    FDA Enforcement
    Class II ·Ongoing·Mirion Technologies (Capintec), Inc.·June 5, 2024

    Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

    FDA Enforcement
    Class II ·Ongoing·Mirion Technologies (Capintec), Inc.·June 5, 2024

    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