BEUDAMED
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    ProLift Lateral Fixated

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INBONE

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420196323·Drill Fixture Removal Tool

    Cotton Trial

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224277·TMC Cotton Trial, 10mm

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·April 27, 2023

    VITAPORT 3

    FDA 510(k)
    FDA Class 2 ·Neurology

    STEALTHSTATION WITH FLUOROMERGE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Neurology

    ASAHI AM-BIO SERIES DIALYZERS

    FDA Adverse Event
    Malfunction ·ASAHI MEDICAL CO., LTD.·Product code MSE·July 16, 2003

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 4, 2019

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 5, 2019

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ZEPHYR XL SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·October 24, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 1, 2013

    MSS - HUMERAL REVERSE LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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