BEUDAMED
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    COMBO MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122987·K-WIRE - SINGLE TROCAR 1.25mm DIA x 150mm

    SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRO WALKER PL-200 POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SPIROPERFECT

    FDA Adverse Event
    Malfunction ·MEDIKRO OY·Product code BZG·August 11, 2023

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 11, 2014

    INRATIO2

    FDA Adverse Event
    Other ·ALERE SAN DIEGO, INC.·Product code GJS·December 17, 2010

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·January 31, 2013

    PFNA-II BLADE L95 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HSB·August 25, 2017

    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