BEUDAMED
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    Multix Fusion Max

    FDA 510(k)
    FDA Class 2 ·Radiology

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331185144·Rhoton Bipolar Bayonet Forceps, round handle, 2...

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107774·TRIAL 90-SRK-191418 POLY-MPCS 4X18 RIGHT

    STAXX(R) XD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008

    NAV 5.5MM TAP (CANNULATED)

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 26, 2013

    UNK JIG

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·July 28, 2011

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    ULTRATHANE SUPRAPUBIC CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOB·August 23, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·July 21, 2021

    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