BEUDAMED
    13 results · 21ms · 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 ×

    MEVION S250i Proton Beam Radiation Therapy Device

    FDA 510(k)
    FDA Class 2 ·Radiology

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023384·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...

    SYNOVO HIP COMPONENTS

    FDA UDI
    Synovo Production·00814193026064·HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28...

    LENSTEC LC INJECTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ACTIVASCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOCKING SCREW, FULLY THREADED 4X28 MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HWC·January 4, 2007

    ACCUTORR V

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC·Product code DXN·May 21, 2013

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS, INC.·Product code LNR·October 10, 2014

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 19, 2008

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·February 11, 2020

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    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