BEUDAMED
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    Endoscopic Injection Needle

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814244·GENUMEDI PT SILVER L VII

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331167126·tissue forceps, standard pattern, serrated hand...

    INFA WARMER I

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VINYL EXAMINATION GLOVE POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 8" (20 C

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·October 9, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2013

    OXFORD UNICOMPARTMENTAL KNEE MENISCAL BEARING

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·July 22, 2011

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 3, 2020

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 2, 2020

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 7, 2020

    IPSOGEN JAK2 PCR KIT IVD

    FDA Adverse Event
    QIAGEN GMBH·Product code PSU·September 4, 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