AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Plato 17 Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

EK12 Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

BAXTER APD 12' EXTENSION LINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Leva Anterior Expandable Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

OnPoint Augmented Reality Spine System

FDA 510(k)

FDA Class 2 ·Neurology

CODMAN QUICK SHUNT KIT, CAT. #82-6570

FDA 510(k)

FDA Class 2 ·Neurology

SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BAXTER CT DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

K SERIES CPAP SYSTEMS

FDA 510(k)

FDA Class 2 ·Anesthesiology

ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

FDA 510(k)

FDA Class 2 ·Ophthalmic

EVA TPN CONTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

IST SNORING APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental

K SERIES CPAP SYSTEMS

FDA 510(k)

FDA Class 2 ·Anesthesiology

FM20

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

URSA ANGIOGRAPHIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX

FDA 510(k)

FDA Class 2 ·General Hospital

SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology