BEUDAMED
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    T-Line Hernia Mesh

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

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111006876·MAYO SCISS DISS STR DEL 5 1/2'

    Symmetry Sofield

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482059258·Symmetry® Retractor, Sofield, 114 x 19 mm and 7...

    SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Intraosseous Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HNM Medical

    FDA UDI
    HNM STAINLESS, LLC.·00842962113844·SOFIELD RETRACTOR, 114MMX19MM AND 76MMX19MM, DO...

    CAPTURE-R READY-SCREEN I AND II

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·February 29, 2016

    FOX SV PTA CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR SWITZERLAND·Product code LIT·November 5, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 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