FACT PLUS ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

eKuore One electronic interface for stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rampart One Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BD Vacutainer® One Use Holder

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RAPID ONE STEP BUPRENORPHINE TEST CARD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PREG-BETA ONE HOUR TUBE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS

FDA 510(k)

FDA Class 2 ·General Hospital

HCG PREGNANCY ONE STEP TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Halo One Thin-Walled Guiding Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUICKPAC II ONE STEP BARBITURATE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KD ONE-STAGE PROTHROMBIN TIME TEST

FDA 510(k)

FDA Class 2 ·Hematology

Arcos One-piece Femoral Revision System

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM

FDA 510(k)

FDA Class 2 ·Orthopedic

ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

FDA 510(k)

FDA Class 2 ·Dental

DBEST ONE-STEP HCG SERUM/URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry