DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

FlexCath Advance Steerable Sheath and Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

LENSX LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

UNIVERSAL STAND FOR FILM CHANGER

FDA 510(k)

FDA Class 2 ·Radiology

PHYCON ALL SILICONE BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

B-CAD SYSTEM, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM

FDA 510(k)

FDA Class 2 ·Anesthesiology

BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

LASER SHIELDING TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CD8 CYTOSPHERES KIT

FDA 510(k)

FDA Class 2 ·Hematology

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC C315 DELIVERY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP

FDA 510(k)

FDA Class 2 ·Neurology

LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Dna-Probe, B And T Lymphocyte

FDA Pre-Market Approval

FDA Class 2 ·ONCOR B/T GENE REARRANGEMENT TEST