OPTIS Integrated System Mobile Workstation

FDA 510(k)

FDA Class 2 ·Radiology

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

FDA 510(k)

FDA Class 2 ·Radiology

SKINTELL

FDA 510(k)

FDA Class 2 ·Radiology

C7 XR IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON

FDA 510(k)

FDA Class 2 ·Anesthesiology

RESTORE*

FDA 510(k)

FDA Class 2 ·Dental

ACCLAIM* BRACKET ADHESIVE

FDA 510(k)

FDA Class 2 ·Dental

ABSORBABLE BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

EXCEL BRACKET ADHESIVE

FDA 510(k)

FDA Class 2 ·Dental

DISTALITE POSTERIA DENTAL RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

RESTOR (COMET)*DENTAL RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT

FDA 510(k)

FDA Class 2 ·Dental

BONDEX* GLASS IONOMER CEMENT

FDA 510(k)

FDA Class 2 ·Dental

CERESTORE DENTIN PORCELAIN

FDA 510(k)

FDA Class 2 ·Dental

CLEANE / CLEANE POP

FDA 510(k)

FDA Class 2 ·Physical Medicine

APEX KIRSCHNER WIRES AND STEINMANN PINS

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON

FDA 510(k)

FDA Class 2 ·Hematology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CONTACT LENSES