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

CHIRON DIAGNOSTICS ACS: 180 FT3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SEDLINE WITH FRONTAL PSI

FDA 510(k)

FDA Class 2 ·Neurology

APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

PNS MAGNETIC STIMULATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery