GI Genius System 100 and GI Genius System 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit

LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ChM 4.5mm Cortical screws

FDA 510(k)

FDA Class 2 ·Orthopedic

DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID)

FDA 510(k)

FDA Class 2 ·Physical Medicine

GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV

FDA 510(k)

FDA Class 2 ·Physical Medicine

GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54

FDA 510(k)

FDA Class 2 ·Physical Medicine

KALMATE MODEL 3A

FDA 510(k)

FDA Class 2 ·Neurology

SuniIQ Digital Radiography System

FDA 510(k)

FDA Class 2 ·Dental

SUNIPAN IMAGING SYSTEM & ACCESSORIES

FDA 510(k)

FDA Class 2 ·Dental

INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY

FDA 510(k)

FDA Class 2 ·Dental

SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SONON Ultrasound Imaging System, Model: 300L

FDA 510(k)

FDA Class 2 ·Radiology

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Certa Catheter

FDA 510(k)

FDA Class 2 ·Anesthesiology

IP SPECIFIC E

FDA 510(k)

FDA Class 2 ·Immunology

IGE EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology