BARD NEONATAL ECG MONITORING ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FTS-100 FLUID TRANSFER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

HealthChek Network Health Station

FDA 510(k)

FDA Class 2 ·Cardiovascular

CANAL KING (THIN) CANAL KING (THICK)

FDA 510(k)

FDA Class 2 ·Dental

LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

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