SELICOR, MODELS A100 & D100

FDA 510(k)

FDA Class 2 ·Physical Medicine

BONESOURCE HYDROXYAPATITE CEMENT (HAC)

FDA 510(k)

FDA Class 2 ·Neurology

CARIES STAIN

FDA 510(k)

FDA Class 2 ·Dental

SECURA IV VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

MyndMove 2.0

FDA 510(k)

FDA Class 2 ·Neurology

EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC

FDA 510(k)

FDA Class 2 ·Dental

LANX SPINAL FIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DENTACOLOR LIGHT CURING CROWN & BRIDGE

FDA 510(k)

FDA Class 2 ·Dental

MOA BONE / M-SPHERE

FDA 510(k)

FDA Class 2 ·Ophthalmic

LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPHTHASONIC A-SCAN/ B-SCAN

FDA 510(k)

FDA Class 2 ·Radiology

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SAVI Dual (TM) Migraine Therapy

FDA 510(k)

FDA Class 2 ·Neurology

CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLYCAR TISSUE REPAIR PATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

FDA 510(k)

FDA Class 2 ·Microbiology

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITALOGRAPH BASE STATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

ENDOVASCULAR GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular