MEDRAD QWIK-FIX MRI DISPOSABLE KIT

FDA 510(k)

FDA Class 2 ·Radiology

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TiLock Modular Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine TiLock Cortical Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDSYNAPSE Zero Footprint Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Medsynapse Ris Pacs & Medsynapse VNA

FDA 510(k)

FDA Class 2 ·Radiology

MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay

FDA 510(k)

FDA Class 2 ·Pathology

EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO

FDA 510(k)

FDA Class 2 ·Orthopedic

PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

EDWARDS ADJUSTABLE CONNECTORS

FDA 510(k)

FDA Class 2 ·Orthopedic

Q-Switched Nd:Yag laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADVANCED TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Protective Face Mask for Medical Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery