ENFLU 18 (enflufocon A) Daily Wear Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

THE KEYMED HI-LIGHT 250 LIGHT SOURCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TITANIUM VENTILATION TUBES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADVIA Centaur Calcitonin (CALCT) assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARC ENDOCUFF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMS 400

FDA 510(k)

FDA Class 2 ·Physical Medicine

SmoothSkin Pure Adapt (SSG3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Wearable Device, Wearable Package

FDA 510(k)

FDA Class 2 ·Cardiovascular

ScopeFlow Pure(TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALIGNRT PLUS

FDA 510(k)

FDA Class 2 ·Radiology

AVELLE Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Perfect PFE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TURBOX THEOPHYLLINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SINGLE USE MANOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

COGNiTiON™ Staple System

FDA 510(k)

FDA Class 2 ·Orthopedic

CLEARVIEW EASY HCG PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LANTOR CUBE STERILIZER TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital