ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOB ONE STEP RAPID TEST

FDA 510(k)

FDA Class 2 ·Hematology

QUICKVUE ONE-STEP ALLERGEN SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

NOVA ONE BLOOD GLUCOSE MONITOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KIMGUARD ONE-STEP STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

MS-ONE, MODEL MS-1

FDA 510(k)

FDA Class 2 ·Physical Medicine

ONE Snare Endovascular Microsnare System

FDA 510(k)

FDA Class 2 ·Cardiovascular

One Step hCG Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXACT ONE(TM) HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

QUIKSTRIP ONE STEP AMPHETAMINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Halyard ONE-STEP* Sterilization Wrap

FDA 510(k)

FDA Class 2 ·General Hospital

ONE-PIECE PEEK FUSION IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

Rhondium One-Visit-Crown(OVC)

FDA 510(k)

FDA Class 2 ·Dental

AQ ONE STEP COCAINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOKUYAMA ONE-UP-BOND F

FDA 510(k)

FDA Class 2 ·Dental

TSolution One Total Knee Application

FDA 510(k)

FDA Class 2 ·Neurology

KIMGUARD ONE STEP STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

NAMIC ONE PART INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Implant-One Multi-Unit Abutment

FDA 510(k)

FDA Class 2 ·Dental

KIMGUARD ONE-STEP STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital