BEUDAMED
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    T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01

    FDA 510(k)
    FDA Class 2 ·Hematology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517576330·CoRoent Ant TLIF Ti, 9x11x36mm 4°

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032115·ET40 MNR T, 2.4G NFM DPB GR ENCHANT 40

    LANX FACET SCREW SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD KIESTRA IDENTIFA

    FDA Adverse Event
    Malfunction ·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008

    SECURE ACUTE CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 28, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2013

    21 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION

    FDA Adverse Event
    Injury ·BECTON DICKINSON, S.A.·Product code FMI·September 8, 2017

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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