Myoject Luer Lock Needle Electrode

FDA 510(k)

FDA Class 2 ·Physical Medicine

INVERNESS MEDICAL EARLY PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RANDOX HAEMOGLOBIN A1C

FDA 510(k)

FDA Class 2 ·Hematology

Compass BDS Biliary Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OLYMPUS IGA REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

GUARDIAN HEMOSTASIS VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLEEK OTW PTA CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

LACTATE DEHYDROGENASE (LD)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DePuy Reclaim Monobloc Revision Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Toricolors (hioxifilcon D) Soft Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OLYMPUS AFP - ALPHA-FETOPROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology