truFreeze System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WELL@HOME SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIS ENGINE

FDA 510(k)

FDA Class 2 ·Neurology

THD SLIDE ONE

FDA 510(k)

FDA Class 2 ·Radiology

SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NON-CORNING (HUBER) NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

M3290B Patient Information Center iX

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOVASIVE 8MM LIGAMENT FASTENER

FDA 510(k)

FDA Class 2 ·Orthopedic

LUMINEXX ENDOSCOPIC BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAGLIFE C

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE

FDA 510(k)

FDA Class 2 ·Dental

IL TEST PROCLOT ASSAY STYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stat Profile Prime Plus Analyzer System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry