ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

R & D BATTERIES, INC. PART # 5003, 5198, 5253

FDA 510(k)

FDA Class 2 ·General Hospital

ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software

FDA 510(k)

FDA Class 2 ·Orthopedic

SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1

FDA 510(k)

FDA Class 2 ·Neurology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SERVICE

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CORDIS WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND TEMPERATURE CABLES

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A)

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology