HUBER CLEAR SAFETY INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

AHMED GLAUCOMA VALVE IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456

FDA 510(k)

FDA Class 2 ·Anesthesiology

0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER

FDA 510(k)

FDA Class 2 ·Radiology

0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER

FDA 510(k)

FDA Class 2 ·Radiology

UCS 1000(TM) WITH TONGUETOUCH KEYPAD WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Neo Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

AHMED ClearPath Glaucoma Drainage Device

FDA 510(k)

FDA Class 2 ·Ophthalmic

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA

FDA 510(k)

FDA Class 2 ·Hematology

NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY

FDA 510(k)

FDA Class 2 ·Dental

ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)

FDA Class 2 ·Microbiology

DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK

FDA 510(k)

FDA Class 2 ·General Hospital

VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442

FDA 510(k)

FDA Class 2 ·Hematology

VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442

FDA 510(k)

FDA Class 2 ·Hematology

WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Revolution External Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic