BEUDAMED
    15 results · 30ms · 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 ×

    AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cool Cassette 2 Size 10XL Instrument Tray Clean Green

    FDA UDI
    PRACTICON, INC.·00723896008959·Building on the success of the original Cool Ca...

    Cool Cassette 2 Size 10XL Instrument Tray True Blue

    FDA UDI
    PRACTICON, INC.·00723896008928·Building on the success of the original Cool Ca...

    Cool Cassette 2 Size 10XL Instrument Tray Cool Coral

    FDA UDI
    PRACTICON, INC.·00723896008935·Building on the success of the original Cool Ca...

    Cool Cassette 2 Size 10XL Instrument Tray Pure Purple

    FDA UDI
    PRACTICON, INC.·00723896008942·Building on the success of the original Cool Ca...

    Cool Cassette 2 Size 10XL Instrument Tray Steel Gray

    FDA UDI
    PRACTICON, INC.·00723896015742·Instrument tray for dental tools

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311419120·

    THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SCB/VALLEYLAB FORCE FX INTERFACE UNIT

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

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 19, 2020

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT VERIO IQ METER

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

    UNICEL® DXC SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 28, 2011

    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