EMS I.V. START KIT

FDA 510(k)

FDA Class 2 ·General Hospital

CRESOLPHTHALEIN COMPLEXONE, CALCIUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOWNLEY COX COMB ACETABULAR COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO VIEWSEND MEDICAL

FDA 510(k)

FDA Class 2 ·Radiology

MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA

FDA 510(k)

FDA Class 2 ·Radiology

HIGH TEMPERATURE CAUTERY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)

FDA 510(k)

FDA Class 2 ·Neurology

OPHTHALMIC CAUTERY

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDRAD QUADRATURE CTL ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC

FDA 510(k)

FDA Class 2 ·Radiology

HIGH TEMPERATURE CAUTERY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TEMPO AND TEMP H20

FDA 510(k)

FDA Class 2 ·General Hospital

TEMPO III

FDA 510(k)

FDA Class 2 ·General Hospital

POS-T-VAC (AVP-1000)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HIGH TEMPERATURE CAUTERY 5 LOOP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

FDA classification

FDA Class 2 ·Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

Enzyme Immunoassay, Methadone

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Methadone

Acid Phosphatase, Thymol Blue Monophosphate

FDA classification

FDA Class 2 ·Acid Phosphatase, Thymol Blue Monophosphate

ELECTRO-LUBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology