ELECTRODE, FLEXIBLE SUCTION COAGULATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AURAVENEER CEMENT

FDA 510(k)

FDA Class 2 ·Dental

EXPEDIUM SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRAILRUNNER GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOCATH ELECTROPHYSIOLOGY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FMS VUE™ Fluid Management and Tissue Debridement System

FDA 510(k)

FDA Class 2 ·Orthopedic

NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM

FDA 510(k)

FDA Class 2 ·Dental

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPIDERX EMBOLIC PROTECTION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNERAD OMNI, MODELS AN6255 AND AN6265

FDA 510(k)

FDA Class 2 ·Radiology

1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION

FDA 510(k)

FDA Class 2 ·Radiology

DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GV 11 (TM), MODEL 9700

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACE TRIMARK TRICAM DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOCERAMIC ORBITAL IMPLANT, ORBTEX

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INFINITY TELESMART TELEMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular