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    IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221038005·Unitek(TM) Bicuspid Band General Purpose Wide L...

    Monterey™ AL

    FDA UDI
    VB Spine LLC·10888857586949·C/C AL Implant Inserter 14/16 mm

    neon™ superior spine system

    FDA UDI
    Ulrich GmbH & Co. KG·04052536007448·neon hook, curved, right

    G-SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEWPORT E360 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·June 27, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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