MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MRI ULTRAVIEW

FDA 510(k)

FDA Class 2 ·Radiology

CARDIO 7

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PS2 Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

MDI SCL-70 TEST

FDA 510(k)

FDA Class 2 ·Immunology

PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QUICKVUE INFLUENZA A+B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

SURGIQUEST ANCHORPORT SIL KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IQVITALS AND IQVITALS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DETER. OF HEMOGLOBIN A2 USING THE DIAMAT

FDA 510(k)

FDA Class 2 ·Hematology

AERO-MIST NEBULIZER HEATER

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS

FDA 510(k)

FDA Class 2 ·Neurology

LYRA ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA

FDA 510(k)

FDA Class 2 ·Ophthalmic

SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology