BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TeraRecon Cardiac.Chambers.MR (1.0.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707040392·DB BRACKETS 22 T-7 A+11 BH CUS U/R

    PROPAQ M

    FDA UDI
    Zoll Medical Corporation·00847946020330·MAIN ASSY, 12LD, SPO2, SPCO, SPMET, NIBP, IBP, ...

    PROPAQ M

    FDA UDI
    Zoll Medical Corporation·00847946017118·Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, SPM...

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517084313·

    Tiger Shark System

    FDA UDI
    Choice Spine, LP·00840996166065·TIGER SHARK,STERILE,STR,9X24X13,12 DEG

    STERILUCENT PROCESS CHALLENGE DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NOBELRONDO DENTAL CERAMIC-ALUMINA

    FDA 510(k)
    FDA Class 2 ·Dental

    COMBISET BLOODLINE

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FJK·August 22, 2011

    PARIETEX COMP 20X15CM OS VERSION X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·November 10, 2014

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 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

    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