AOI CRANIAL HELMET

FDA 510(k)

FDA Class 2 ·Neurology

AOI UNIVERSAL ULTRASONIC HANDPIECE

FDA 510(k)

FDA Class 2 ·Ophthalmic

AOI LC-40 PHACOEMULSIFIER

FDA 510(k)

FDA Class 2 ·Ophthalmic

KOI PACHYMETER

FDA 510(k)

FDA Class 2 ·Radiology

KOI BLUE FIELD ENTOPTOSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL

COOLBLU CURING LIGHT

FDA 510(k)

FDA Class 2 ·Dental

URISCAN OPTIMA II URINE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COOLBLU2 DENTAL RESIN CURING DEVICE

FDA 510(k)

FDA Class 2 ·Dental

ASCENDX VCF REDUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED POC BANDIT PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED POC BANDIT PTCA CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Ureteral Stent Systems, Biliary Drainage Catheters

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43R HYDROPHILIC CONTACT LENS