DIO SM IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI COLOURS CONTACT LENSES

ASI Plethysmogrpah Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASI HEMOSTASIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASI CYSTOLASE LASER CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASI UROPLASTY LASER CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIRPREP SYSTEM - MODEL 9001

FDA 510(k)

FDA Class 2 ·Dental

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES

FDA 510(k)

FDA Class 2 ·Dental

FC-1000 FLUOROSCOPIC IMAGING COMPUTER

FDA 510(k)

FDA Class 2 ·Radiology

PRESTIGE AMERITECH FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

FDA 510(k)

FDA Class 2 ·General Hospital

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

BICART

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMASATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hysteroscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Vitrea View

FDA 510(k)

FDA Class 2 ·Radiology

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL

FDA 510(k)

FDA Class 2 ·General Hospital

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology