ALPHA URINE SAMPLE

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

AMIZYME-TOXOPLASMA GONDII KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIO Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASTHMAPOLIS SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

CARDIAC VIEW, MODEL 2001

FDA 510(k)

FDA Class 2 ·Radiology

miraDry System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KOALA

FDA 510(k)

FDA Class 2 ·Radiology

TRANSYSTEM AMIES WITH CHARCOAL

FDA 510(k)

FDA Class 1 ·Microbiology

INTRAVASCULAR ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

MIRACLEBREATH TONGUE CLEANER

FDA 510(k)

FDA Class 1 ·Dental

URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PNEUMOPERITONEUM INSUFFLATION NEEDLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C

FDA 510(k)

FDA Class 2 ·Physical Medicine

PLATELET AGITATOR

FDA 510(k)

FDA Class 1 ·Hematology

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)

FDA 510(k)

FDA Class 1 ·Physical Medicine

RELIEF BAND (T.E.N.S. DEVICE)

FDA 510(k)

FDA Class 2 ·Neurology

SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)

FDA 510(k)

FDA Class 2 ·Neurology