BEUDAMED
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    EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517565297·CoRoent Ant TLIF PEEK, 13x12x30mm 4°

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138104785·NEOPRENE SLIP-ON ELBOW SLEEVE, XLARGE

    AGXO

    FDA UDI
    Oticon A/S·05707131258076·H150, MINIBTE 312 WL 85 STG AGXO

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857560642·Trial With Stop Size 12x14x7 mm, 4 Degrees

    HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    BREEZE C MODEL C (3W), BREEZE C (4W)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973547·

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 7, 2020

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 11, 2015

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    LINOX SD 65/18

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO., KG·Product code LWS·June 13, 2011

    GYNECARE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTO·November 17, 2017

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 3, 2025

    BBL TSA II w/5% Sheep Blood, Spacesaver - Catalog Number 292537.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JSO·July 2, 2004

    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