HOSPITAL LAB IN-HOME EARLY PREG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Distinct® Early Detection Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARPLAN EASY II HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FACTPLUS ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDELA CLARIO HOME CARE PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CATHETER VALVES KV 100 & KV 100EH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FD TENS 2050 OR SLIDE TENS MODEL FD2050

FDA 510(k)

FDA Class 2 ·Neurology

BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E

FDA 510(k)

FDA Class 2 ·Physical Medicine

MINI PATCH

FDA 510(k)

FDA Class 2 ·Neurology

PICA WHOLE-BODY MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

HTS EXTREMITY COIL, HTS SURFACE COIL

FDA 510(k)

FDA Class 2 ·Radiology

LERADO, POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

GYMFORM DUAL FLEX BELT MODEL WB-162

FDA 510(k)

FDA Class 2 ·Physical Medicine

FD TENS 2070

FDA 510(k)

FDA Class 2 ·Neurology

OREGON SCINTIFIC

FDA 510(k)

FDA Class 2 ·Cardiovascular