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    IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150713·K-WIRE - SINGLE TROCAR 1.0mm DIA x 100mm

    PRIMA 236-02 NONPROGRAMMABLE CARDIAC

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CLEARBLUE EASY EASY READ PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 29, 2010

    REFURB FR2+ AED, NO ECG, US ENGLISH

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 31, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2014

    HANDLE WITH MINI QUICK COUPLING

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWX·May 30, 2024

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020

    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