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

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    COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN

    FDA 510(k)
    FDA Class 2 ·Hematology

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885554007565·SOD OBT 5.0 J-LCK FOR CANN &

    Stryker F1

    FDA UDI
    STRYKER CORPORATION·07613327072051·SmartGrip Insert Tray

    N/A

    FDA UDI
    STRYKER CORPORATION·07613327657821·Battery Insert Tray - Bottom

    MASIF POWDER-FREE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SINUS QUICK EB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 21, 2020

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·June 23, 2020

    PFC*SIGMA/OV/DOME PAT 3PEG,38

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043·Product code JWH·June 27, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 16, 2010

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·January 7, 2013

    MENTOR SMOOTH ROUND HIGH PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 1, 2020

    PIRANHA

    FDA Adverse Event
    Injury ·RICHARD WOLF GMBH·Product code JCX·January 5, 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