BEUDAMED
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    SpotLight/SpotLight Duo (with DLIR option)

    FDA 510(k)
    FDA Class 2 ·Radiology

    EarQ

    FDA UDI
    Sbo Hearing A/S·05714464030002·EARQ F40 MINIRITE T C063

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540177421·BIPOLAR FORCEPS

    REDLINE ANTHRAX ALERT TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS INC.·Product code QFG·December 15, 2025

    VALVE XS DE'BAKEY FCPS STR.WIDE 230/370

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code HTD·June 11, 2025

    CVC KIT: 3-LUMEN 7 FR X 16 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQO·November 7, 2008

    ECHELON 60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 1, 2011

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    Allura Xper FD20 Biplane; Model Number: 722013;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025