OnX Tough

FDA 510(k)

FDA Class 2 ·Dental

ONX Large External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENESIS HEALTH RECORD SYSTEM, (GHRS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RHEOLOGIC I

FDA 510(k)

FDA Class 2 ·Physical Medicine

OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIGMA ELITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)

FDA 510(k)

FDA Class 2 ·Orthopedic

CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

FDA 510(k)

FDA Class 2 ·Ophthalmic

MIRADA XD

FDA 510(k)

FDA Class 2 ·Radiology

MIRADA RT

FDA 510(k)

FDA Class 2 ·Radiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·IDEL 67 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·IGEL 67 CONTACT LENS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER COMPACT S

1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMT HALO SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

1351 UROFLOW AUTO START

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology