Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

SpotLight/SpotLight Duo (with DLIR option)

FDA 510(k)

FDA Class 2 ·Radiology

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AutoStrut G2

FDA 510(k)

FDA Class 2 ·Orthopedic

A-V IMPULSE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

WBR XPRESS3.CARDIAC

FDA 510(k)

FDA Class 2 ·Radiology

SWIFT FX NANO

FDA 510(k)

FDA Class 2 ·Anesthesiology

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Gallant PTCA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hepatica v1 (Hepatica v1.0.0)

FDA 510(k)

FDA Class 2 ·Radiology

FFRangio

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXPRESS MINI GLAUCOMA SHUNT

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EAST WATER UNIT MARK 3

FDA 510(k)

FDA Class 2 ·Cardiovascular

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUPERDIMENSION/BRONCHUS PREMIUM

FDA 510(k)

FDA Class 2 ·Radiology

DIOMED 15 DIODE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VPAP ST-A

FDA 510(k)

FDA Class 2 ·Anesthesiology