BEUDAMED
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    ACUMATCH GXL 15DEG LINER 36MM SZ J

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·April 19, 2024

    ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017

    MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Immunology

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009

    INTIMA-II Y 24GAX0.75IN MZ PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·Product code FOZ·August 31, 2021

    ENRHYTHM MRI

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·April 10, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011

    DUAL LUMEN CATHETER, TAPERED SEGMENT, 10 FR, 5/PK

    FDA Adverse Event
    Malfunction ·GYRUS MEDICAL INC.·Product code DQO·May 16, 2008

    LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    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