SOLOS EYESITE SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

FEMCHEC PRESSURE MANAGEMET DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CYGNUS™ Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPINA SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

ATLAS Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

Z-CLAMP FORCEPS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIAMOND RATTLESNAKE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

FDA 510(k)

FDA Class 2 ·Immunology

DK-PTCA BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010

FDA 510(k)

FDA Class 2 ·General Hospital

CORMATRIX ECM FOR VASCULAR REPAIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS

FDA 510(k)

FDA Class 2 ·Hematology

BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DORNIER SCANNER HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AVL OMNI ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

FDA 510(k)

FDA Class 2 ·Microbiology

MAX IT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology