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    VERSAPORT V2 BLADELESS OPTICAL TROCAR

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

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776306472·CUSHING TISS FCPS 7 1X2TSERR GUTSCH HNDL

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433408·Integra® Jarit® Cushing Dressing and Tissue For...

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925018457·FARRIOR RASP .50 MM TIP DIAMETER STAINLESS STEE...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1304350·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450335703·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450332306·

    BIOUNIVERSAL PKF

    FDA 510(k)
    FDA Class 2 ·Dental

    AMEDA PLATINUM BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 24, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 30, 2014

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 16, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    INSPIRE 6F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    RESERVOIR INSPIRE 8

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026

    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025

    INSPIRE HARD VENOUS RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023