DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE SYSTEM 3

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

GSI AUDERA

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POTTY PAGER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONMED MACROLYTE DISPERSIVE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

READS(R) ANTI-ENA (SM/RNP) TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

PRESTO DIAGNOSTIC SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

AQUA MERON

FDA 510(k)

FDA Class 2 ·Dental

SONATA 3-D IMAGING ACCESSORY, MODEL 3DS

FDA 510(k)

FDA Class 2 ·Radiology

CAPNOGRAPHY PAD (92516)

FDA 510(k)

FDA Class 2 ·Anesthesiology

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH

FDA 510(k)

FDA Class 2 ·Dental

AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)

FDA 510(k)

FDA Class 2 ·Ophthalmic

FluChip-8G Influenza A+B Assay

FDA 510(k)

FDA Class 2 ·Microbiology