PERCUPRO MESSENGER BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SpaceOAR Vue Hydrogel

FDA 510(k)

FDA Class 2 ·Radiology

SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CYNOSURE DIODERM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHRONOS VISION EYE TRACKING DEVICE (C-ETD)

FDA 510(k)

FDA Class 2 ·Neurology

NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SABRE MULTI-USE TROCAR SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TempSure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULTRASUN 2500 SUNTANNING UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID

FDA 510(k)

FDA Class 2 ·Cardiovascular

KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MONOGRAM II

FDA 510(k)

FDA Class 2 ·Dental

XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULPDENT MICRO-HYBRID COMPOSITE

FDA 510(k)

FDA Class 2 ·Dental

ARTHRO-SURGIMAT-2000 ECU

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE

FDA 510(k)

FDA Class 2 ·Dental

SUCTION TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RTS TECHNOLOGY MODELS 721,722,723,724

FDA 510(k)

FDA Class 2 ·Radiology