LIGHTSTREAM LOW LEVEL LASER

FDA 510(k)

FDA Class 2 ·Physical Medicine

BONASTENT TRACHEAL / BRONCHIAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GASTRIC AND RECTAL CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Fusion Bx 2.0

FDA 510(k)

FDA Class 2 ·Radiology

DISTENDER SERIES II BAROSTAT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BONASTENT BILIARY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Fusion Bx

FDA 510(k)

FDA Class 2 ·Radiology

BrightMatter Guide with BrightMatter Pointer

FDA 510(k)

FDA Class 2 ·Neurology

BRIGHTMATTER NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BrightMatter Guide with Surface Trace Registration

FDA 510(k)

FDA Class 2 ·Neurology

Synaptive ImageDrive Pro

FDA 510(k)

FDA Class 2 ·Radiology

Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC C315 DELIVERY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

FDA 510(k)

FDA Class 2 ·Pathology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

AERO-MIST NEBULIZER HEATER

FDA 510(k)

FDA Class 2 ·Anesthesiology

MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE

FDA 510(k)

FDA Class 2 ·Cardiovascular