BEUDAMED
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    KIMGUARD ONE-STEP STERILIZATION WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814565·GENUMEDI SAND SIZE V

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006793·4700B SERIES NON HTD PTM

    Hemostat Forceps

    FDA UDI
    Medetz Surgical Instruments LLC·G2231128050·Hartmann mosquito forceps, 3 3/4", curved 20mm ...

    Working Tube

    FDA UDI
    ELLIQUENCE, LLC·00846338006334·

    T-Crystal cartridges Clear

    FDA UDI
    PERFLEX LTD·07290110506254·5 identical cartridges sealed in a vacuum bag ;...

    AUTOMARQER

    FDA 510(k)
    FDA Class 2 ·Hematology

    GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 14, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·April 29, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013

    Depuy LCS Complete RP insert; polyethylene tibial insert STD+, 15 mm; Ref 1294-05-515.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    cobas 8000 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