BEUDAMED
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    Treace Medical Concepts (TMC) Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419372·Integra® Miltex® House-Sheehy Knife Curette, 6"...

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973684·

    FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM

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

    ZOLL IVTM ICY CATHETER

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·December 29, 2023

    1550 HEMODIALYSIS MACHINE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORP.·Product code FKP·December 14, 2000

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 13, 2017

    CORTSCR Ø3.5 L32 TI

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HWC·June 27, 2013

    TROCHANTERIC NAIL KIT, TI 11 X 180 MM X 130

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 30, 2011

    RADIAL JAW 4 BIOPSY FORCEPS

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

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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