BEUDAMED
    18 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 ×

    E-Z EM PERCUPUMP 2001 CT INJECTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aria

    FDA UDI
    INTELLIGENT HEARING SYSTEMS CORP.·00817020021126·

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048438005408·Electrode, bipolar

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED

    VERSABOND BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WILLI GELLER CREAPEARL

    FDA 510(k)
    FDA Class 2 ·Dental

    ELECTRODE, BIPOLAR

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code FAS·October 23, 2024

    ELECTRODE, BIPOLAR

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code FAS·October 23, 2024

    DISPOSABLE ELECTROSURGICAL SNARE

    FDA Adverse Event
    Other ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·March 14, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 8, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    UNIVERSAL STUMP APPLICATOR SET

    FDA Adverse Event
    Injury ·VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS·Product code JAQ·December 11, 2017

    M2A ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    cobas 8000 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

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014