KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Insulin Autoantibody Kit

FDA classification

FDA Class 2 ·Insulin Autoantibody Kit

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

ICAN GT DRAINAGE BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ICAN NEEDLE COUNTERS

FDA 510(k)

FDA Class 2 ·General Hospital

(SPAG) MODEL SPAG-2 6000 SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

WATER COLUMN RELIEF VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

CONFOCAL MICROSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

LightStim for Acne/ LightStim for Acne Mini

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITRE CON

FDA 510(k)

FDA Class 2 ·Ophthalmic

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Constellation (CON-001)

FDA 510(k)

FDA Class 2 ·Radiology

Pulsaderm Acne Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANTIASTHMATIC CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology