BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    SPINE ALIGN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209138043·

    KONIX ULTRASOUND GEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNERGY SPINAL SYSTEM (6.35 POLARIS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCELSTIM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LOF·June 5, 2023

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·October 23, 2012

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 28, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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