BEUDAMED
    16 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.

    OXYTOTE INFINITY SERIES VIPR SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    GAUNYING INFRARED LAMP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    WEIGHT AND BODY FAT SCALE SHINE BS0105

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 3, 2021

    PLATE OTIS-C PLUS RIGHT

    FDA Adverse Event
    Injury ·S.B.M. SAS·Product code HRS·May 21, 2019

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 5, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013

    COBAS TAQSCREEN MPX TEST

    FDA Adverse Event
    ROCHE MOLECULAR SYSTEMS·Product code MKT·June 28, 2011

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·September 15, 2017

    ENDEAVOR RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·September 15, 2017

    VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM

    FDA Adverse Event
    Death ·COVIDIEN·Product code FGE·September 15, 2017

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·January 12, 2021

    TRUE METRIX

    FDA Adverse Event
    Injury ·TRIVIDIA HEALTH INC·Product code NBW·December 5, 2024

    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021

    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