STARCAST DENTAL ALLOYS

FDA 510(k)

FDA Class 2 ·Dental

CARDIOBEEPER(R) CB-IIA

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS

FDA 510(k)

FDA Class 2 ·General Hospital

ASAHI AM SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEM 2400 PET SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

DEEPVISON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOFLEX

FDA 510(k)

FDA Class 2 ·Orthopedic

CORIN BIPOLAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HI SONIC 2000 DIGITAL HEARING INSTRUMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIPOSONIX SYSTEM, MODEL 1 P00XXXX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCULIF TL AND PL CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B

FDA 510(k)

FDA Class 2 ·Anesthesiology

ENABLER-P CATHETER SYSTEM, MODEL 3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

KOWA AUTOMATED TONOMETER KT-500

FDA 510(k)

FDA Class 2 ·Ophthalmic

ESTELITE COLOR

FDA 510(k)

FDA Class 2 ·Dental

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology