SancDam Latex Oral Dam

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

EPI-SCAN, MODEL P 100

FDA 510(k)

FDA Class 2 ·Neurology

Aperta NSE PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Veloxion System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SNOAR(TM) OPEN AIRWAY APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS

FDA 510(k)

FDA Class 2 ·Hematology

PATHIAM IMAGING SOFTWARE FOR HER2/NEU

FDA 510(k)

FDA Class 2 ·Hematology

Gatekeeper Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aveta System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

FDA 510(k)

FDA Class 2 ·Ophthalmic

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PENSIL TRAUMA, MODEL WWS6100

FDA 510(k)

FDA Class 2 ·Radiology

EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology