Biomet Spine Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUMIWAVE 1X4 INFRARED THERAPY DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

COBE CENTRYSYSTEM CS500 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMEX STETHODOP

FDA 510(k)

FDA Class 2 ·Radiology

PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

TRAVONEB MODEL # TONE 1

FDA 510(k)

FDA Class 2 ·Anesthesiology

DENTRAY II PLUS TRAY ADHESIVE

FDA 510(k)

FDA Class 2 ·Dental

TransForm McCarthy Mitral Annuloplasty Ring (TF)

FDA 510(k)

FDA Class 2 ·Cardiovascular

GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS

FDA 510(k)

FDA Class 2 ·Dental

ECONO MATE

FDA 510(k)

FDA Class 2 ·Anesthesiology

STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234

FDA 510(k)

FDA Class 2 ·General Hospital

HORIZON/WESTHIN 55-G

FDA 510(k)

FDA Class 2 ·Ophthalmic

PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

REAADS IGG ANTI-B2GPI TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAVITY VARNISH PRODUCT

FDA 510(k)

FDA Class 2 ·Dental

AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CENTRYSYSTEM 3 WITH CHARTS/BP OPTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Angel Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular