BEUDAMED
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    Filters Regulation: Us FDA ×

    Hybernite RT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837087975·

    HNM SPORTS MEDICINE

    FDA UDI
    HNM STAINLESS, LLC.·00842962101896·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 6mm...

    RADIFOCUS GLIDEWIRE M

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

    BD DIRECTIGEN EX FLU A+B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    3I OSSEOTITE DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    HNM SPORTS MEDICINE

    FDA UDI
    HNM STAINLESS, LLC.·00842962104101·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 6mm...

    ORS-320N SOLUTION WARMER DRAPE

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·June 22, 2016

    NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 15MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 4, 2023

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    PLMA DVC V11.51 1 N

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD·Product code FRN·May 30, 2013

    ENDOTAK PLUS

    FDA Adverse Event
    Injury ·HISTORICAL PUERTO RICO·Product code NVY·July 6, 2011

    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