PAN (CHIBA ASPIRATING NEEDLE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TR NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CapsoCam (SV-1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CDC ZIRCONIA BLANKS

FDA 510(k)

FDA Class 2 ·Dental

MIRAGE BOND

FDA 510(k)

FDA Class 2 ·Dental

Patient Positioning Devices

FDA 510(k)

FDA Class 2 ·Radiology

WALLANT NEUROLOGIX GENERAL PURPOSE TENS

FDA 510(k)

FDA Class 2 ·Neurology

WALLANT NEUROLOGIX DUAL PUR NERVE/NEUROMUSCU STIMU

FDA 510(k)

FDA Class 2 ·Neurology

KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Sphere-9Dx Diagnostic Catheter (AFR-00009)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aperta NSE PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

GALLINI COAXIAL INTRODUCER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CapsoCam Plus (SV-3)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CapsoCam Plus (SV-3) Capsule Endoscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Zimed Distal Medial Tibial Plate and Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14

FDA 510(k)

FDA Class 2 ·Anesthesiology