BEUDAMED
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    Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

    FDA 510(k)
    FDA Class 2 ·Hematology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Bernafon

    FDA UDI
    Bernafon AG·05711584077740·AQ CO5 B 105, 2.4G NFM DPB MSIL/MAC ACCUQ

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026339·Deaver Ret, 8 1/2", width 7/8", #00

    Calcar Reamer

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215055561·

    APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER

    FDA 510(k)
    FDA Class 2 ·Immunology

    ESIE APPS SUITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·March 6, 2019

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 2, 2008

    XENOFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·June 17, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 22, 2011

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018