BEUDAMED
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    da Vinci SP Surgical System (SP1098)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Cascadia™ Interbody System

    FDA UDI
    VB Spine LLC·10888857369535·Trial, Size 12x14x7 mm, 7°

    Powerheart G5 AED

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2023

    POWERHEART G5 AUTOMATIC AED

    FDA Adverse Event
    Malfunction ·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 11, 2014

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 25, 2008

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 12, 2011

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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