BEUDAMED
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    CHILDRENS SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978080123·DISTRACTOR 902-225 16MM 8/10MM

    OR TABLE/MAGNETOM OPEN VIVA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 24, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·January 8, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 18, 2010

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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