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

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

S-ROM FEMORAL HIP STEM - SIZE 14 X 8

FDA 510(k)

FDA Class 2 ·Orthopedic

Hoffmann LRF System

FDA 510(k)

FDA Class 2 ·Orthopedic

EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE

FDA 510(k)

FDA Class 2 ·General Hospital

INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KNEEALIGN SYSTEM WITH REFERENCE SENSOR

FDA 510(k)

FDA Class 2 ·Neurology

SHILEY PERFUSION TUBING SETS

FDA 510(k)

FDA Class 2 ·Cardiovascular

GEL MARK V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABSORBABLE BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic