BEUDAMED
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    LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green

    NA

    FDA UDI
    STERILMED, INC.·10888551021210·BUR DIAMOND ROUND MEDIUM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450165805·

    V10-4 Ultrasonic Transducer(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089355·

    E-Z EM PERCUPUMP 2001 CT INJECTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERSABOND BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    GAS RESPIRATION MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC·Product code BZK·April 30, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 20, 2011

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013

    cobas 8000 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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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