Sprint Quattro Secure S®

FDA UDI

MEDTRONIC, INC.·00643169550971·LEAD 6947M97 SPRINT US DF4 MCRD NG ACI

ACIS® ProTi 360™ HL

FDA UDI

Tyber Medical LLC·00819917022254·ACIS PROTI 12 DG HL L 9MM H

MRI- FLOW ANALYTICAL SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

ORTHO-CMS

FDA 510(k)

FDA Class 2 ·Radiology

QBRAIN

FDA 510(k)

FDA Class 2 ·Radiology

QPLAQUE MR

FDA 510(k)

FDA Class 2 ·Radiology

MRA-CMS

FDA 510(k)

FDA Class 2 ·Radiology

CT-MASS

FDA 510(k)

FDA Class 2 ·Radiology

QANGIO CT

FDA 510(k)

FDA Class 2 ·Radiology

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

RSA-CMS

FDA 510(k)

FDA Class 2 ·Radiology

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TCI HEARTMATE IP LVAS

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·Cartiva SCI reusable instrumentation

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TCI HEARTMATE VE LVAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TCI HEARTMATE VE LVAS

ACTHK-PR RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BCI WW1021 PC APPLICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI WW1030 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular