BEUDAMED
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    Humelock TiN Coated Glenosphere

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Obturator

    FDA UDI
    SOPRO-COMEG GmbH·04059082032887·

    MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    WATER BOTTLE CAP SYSTEM

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

    HT70 PLUS VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 25, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 26, 2013

    HYDRATOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 26, 2008

    UNKNOWN MAE GENERATOR

    FDA Adverse Event
    Injury ·MEDTRONIC ADVANCED ENERGY (SALIENT)·Product code GEI·October 13, 2022

    SUBDURAL ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GYC·August 18, 2025

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018