BEUDAMED
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    HS186B Scooter

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BD Difco™ Salmonella H Antiserum L Complex

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902227113·BD Difco™ Salmonella H Antiserum L Complex, 3 mL

    Plateau V & Z

    FDA UDI
    Life Spine, Inc.·00190837073428·Plateau V Spacer, 12mm x 22mm x 11mm,7 degree

    FACIAL SPA

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO AVALON CUP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFERIOR END PLATE LARGE-STERILE

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·November 4, 2014

    CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTM·July 26, 2011

    ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 12, 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

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    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