BEUDAMED
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    NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122970·K-WIRE - SINGLE TROCAR 1.1mm DIA x 150mm

    VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2013

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 8, 2010

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·July 17, 2014

    ONE TOUCH PING METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·February 25, 2010

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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