BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

FDA 510(k)

FDA Class 2 ·Microbiology

SELECTRA AND TUBING SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRX-CG POWER TILT AND RECLINE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

CEDARA I-RESPONSE CEDARA PET/CT

FDA 510(k)

FDA Class 2 ·Radiology

VAX-T PELVIC TRACTION BELT

FDA 510(k)

FDA Class 2 ·Physical Medicine

EEG WITH VIDEO, MODEL EX-NW

FDA 510(k)

FDA Class 2 ·Neurology

MADSEN IGO1500 INSERTION GAIN OPTIMIZER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

REGEN SPRAY APPLICATOR,

FDA 510(k)

FDA Class 2 ·General Hospital

NEW ALLEN IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

Cardio-TriTest v6.5

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERIZONE(R) VP4 Sterilizer

FDA 510(k)

FDA Class 2 ·General Hospital

ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10

FDA 510(k)

FDA Class 2 ·Hematology

Harmony Latex Dam, Harmony Non-Latex Dam

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology

CRYO CHECK INR VALIDATION SET

FDA 510(k)

FDA Class 2 ·Hematology

BIOLOGICAL SOUND MONITOR (BSM) SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular