BEUDAMED
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    VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ITOTAL OVAL PATELLA TRIAL 29MM

    FDA UDI
    Conformis, Inc.·00810933030407·

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114588·LOCATOR F-Tx Abutment for 4.3mm CAMLOG Connecti...

    Symmetry Olsen

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00841785110498·

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110979·LOCATOR R-Tx Abutment for 4.3mm Camlog Connecti...

    BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HARDYDISK, STREPTOMYCIN 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    PRECISION? MONTAGE? MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 4, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 26, 2013

    TOTAL CARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 6, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·July 22, 2008

    BENCHMARK ULTRA

    FDA Adverse Event
    Malfunction ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 26, 2024

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 4, 2022

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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