BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    API UNISCEPT PLUS AUTOINOCULATOR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STICK FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.

    FDA Enforcement
    Class II ·Terminated·Sysmex America, Inc.·November 14, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 24, 2014

    VORTX¿ DIAMOND - 18

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRD·November 14, 2012

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 25, 2007

    Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GKZ·June 1, 2012

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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