PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASAHI AM SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

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

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

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LAFACI

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WATCH-PAT MODEL 100S-2

FDA 510(k)

FDA Class 2 ·Anesthesiology

S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

MONOCLONAL ANTIBODY T4 RADIO-KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO-OSS COLLAGEN

FDA 510(k)

FDA Class 2 ·Dental

CHALLENGE 6010 POWERED MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

REJUVENIQUE MODEL #RJV10

FDA 510(k)

FDA Class 2 ·Neurology