BEUDAMED
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    ARIX Small Fragment System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112373·CHUCK HANDLE #3KA 7.5CM LONG

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730008060·Votion .022 MC UR 4/5 G/O -7T 0A 0O (10PK)

    Pinnacle

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730009890·Pinnacle .022 MC UR 4/5 G/O -7T 0A 0O (10PK)

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113759·Votion .022 MC UR 4/5 G/O -7T 0A 0O (10PK)

    Pinnacle®

    FDA UDI
    Ortho Organizers, Inc.·00190707111885·Pinnacle .022 MC UR 4/5 G/O -7T 0A 0O (10PK)

    LASERBRUSH

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    7.0 FR. ENDOBRONCHIAL BLOCKER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·January 30, 2013

    PREMIUM PLUS CEEA 28 INSTR W/TILT TOP

    FDA Adverse Event
    Injury ·PONCE - USS·Product code GDW·November 4, 2008

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·August 17, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 5, 2013

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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