ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHILIPS DIGITAL IMAGING OPTION RELEASE 1

FDA 510(k)

FDA Class 2 ·Radiology

THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMICON MINIFILTER PLUS HEMOFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON

FDA 510(k)

FDA Class 2 ·Cardiovascular

LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANAL KING (THIN) CANAL KING (THICK)

FDA 510(k)

FDA Class 2 ·Dental

PICOSURE WORKSTATION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NXSTAGE SYSTEM ONE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUNDT SLIM-LINE ANEURYSM CLIP APPLIER

FDA 510(k)

FDA Class 2 ·Neurology

INTRA-AORTIC BALLOON (IAB)

FDA 510(k)

FDA Class 2 ·Cardiovascular

THERATEARS CONTACT LENS COMFORT DROPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

UNICATH FAMILY

FDA 510(k)

FDA Class 2 ·Radiology

CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

LANDERS-FOULKS TEMP. KERATOPROSTHESIS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CHIRON DIAGNOSTICS ACS: 180 FT3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACUSON S3000, S2000 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology