VNS Therapy® Model 250 v8.1 Programming Software (X50)

FDA UDI

LIVANOVA USA, INC.·05425025750184·Programming Software

VNS Therapy® Programmer, Model 3000 v1.0

FDA UDI

LIVANOVA USA, INC.·05425025750399·Programmer

VNS Therapy™ Programmer, Model 3100 v1.1.0

FDA UDI

LIVANOVA USA, INC.·05425025750634·Programmer and Software

MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NSK Sterile Burs/Drills

FDA UDI

NAKANISHI INC.·04560264515444·

ALARA Neuro Access Needle Kit

FDA UDI

SURGENTEC, LLC·00858406007310·ALARA Neuro Access Needle Kit Two Pack - Diamo...

CareTip

FDA UDI

GBUK ENTERAL LIMITED·05060590883655·CareTip, Oral Syringe, Amber Barrel, Single Use...

ALARA Neuro Access Needle Kit

FDA UDI

SURGENTEC, LLC·00858406007303·ALARA Neuro Access Needle Kit Two Pack - Diamon...

NSK Sterile Burs/Drills

FDA UDI

NAKANISHI INC.·04589551350292·

ALARA Neuro Access Needle Kit

FDA UDI

SURGENTEC, LLC·00858406007327·ALARA Neuro Access Needle Kit Two Pack - Bevel Tip

NSK Sterile Burs/Drills

FDA UDI

NAKANISHI INC.·04560264515437·

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Big-Tip

FDA UDI

RF Medical Co.,Ltd.·08809295149324·

ElectrodeCRF

FDA UDI

CAMBRIDGE INTERVENTIONAL LLC·00811746032022·CRF Radiofrequency Electrode