BEUDAMED
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    MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

    FDA 510(k)
    FDA Class 2 ·Dental

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00193493934225·AVANOS* Single-Shot Epidural Trays

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651934229·HYH,EP TRY,S-SHOT,-,-,10

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·December 9, 2019

    VITEK 2 STREPTOCOCCUS LEVOFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PLANISIGHT LINASYS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOSS MIAMI SI FINAL TIGHTENER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code HXX·October 17, 2014

    MICRUS MICROCOIL SYSTEM

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR CORPORATION·Product code HCG·July 12, 2011

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·June 14, 2013

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 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