BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199090·AK3 Congruent Insert Trial Size 4, 13mm

    Orthos

    FDA UDI
    ORMCO CORPORATION·00889989030075·ORTHOS CM SST 021 X 025 UPLG PK10

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331184994·Rhoton Bipolar Bayonet Forceps, round handle, 0...

    S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EUROMI EVA SP6

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OBTRYX SYSTEM - HALO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 5, 2019

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·June 26, 2013

    SCORPIO FIXD BPLATE PA SIZE 11

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code MBH·July 28, 2011

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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