BEUDAMED
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    CORTRAK ENTERAL ACCESS DEVICE

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

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104530·PS3 Screw 10.5mm x 35mm

    Pilot Spinal System

    FDA UDI
    Life Spine, Inc.·00190837051440·Pilot Plate Accessory Caddy

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code PMP·September 25, 2022

    TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DMC COMPOSITE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code PMP·April 25, 2025

    *

    FDA Adverse Event
    Malfunction ·*·Product code FPK·April 24, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2011

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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