ENDOSCOPIC APPLICATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER SIZING BALLOON

FDA 510(k)

FDA Class 2 ·Cardiovascular

NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408

FDA 510(k)

FDA Class 2 ·Dental

DuoFLEX Coil Suite

FDA 510(k)

FDA Class 2 ·Radiology

Imbio RV/LV Software

FDA 510(k)

FDA Class 2 ·Radiology

WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENGAGE/ENGAGE TR INTRODUCERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

SpeediCath Compact Eve

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LTV 1000 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

VIDAS TBI (GFAP, UCH-L1)

FDA 510(k)

FDA Class 2 ·Immunology

QBC VENOUS BLOOD CONTROL/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

CONKLUSION PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BONALIVE GRANULES AND BONALIVE PLATES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRUEPATH CTO DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

4000+

FDA 510(k)

FDA Class 2 ·Physical Medicine

PEZO INTERBODY CAGES SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic