GSI 70 AUDIOPATH SCREENER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GSI 2000 MIDDLE EAR ANALYZER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GSI VIEWER WITH VUE OPTION

FDA 510(k)

FDA Class 2 ·Radiology

GSI TympStar Pro Middle Ear Analyzer

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THE SCREENER GSI 55 ABR SCREENER

FDA 510(k)

FDA Class 2 ·Neurology

Thoracic VCAR with GSI Pulmonary Perfusion

FDA 510(k)

FDA Class 2 ·Radiology

DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)

FDA 510(k)

FDA Class 2 ·Radiology

PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

FDA 510(k)

FDA Class 2 ·Microbiology

ASI REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASI Evolution

FDA 510(k)

FDA Class 2 ·Microbiology

SRH-678 VACCUUM TUBING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRF CHARCOAL CANISTER REPLACEMENT FILTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASI Plethysmogrpah Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASI HEMOSTASIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Light based hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIGMA ELITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

TiLink-P Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Synxess Neurovascular Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI COLOURS CONTACT LENSES