BEUDAMED
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    LOSPA II Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074520544·SPACER 9192507 CRESCENT PEEK 25X7

    AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZIT-Z

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 3, 2024

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

    SWEAT BANDS

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code LYU·October 22, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 19, 2013

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA, LTD.·Product code MMI·June 30, 2011

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    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