OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-38 (POLYMACON)

FDA 510(k)

FDA Class 2 ·Ophthalmic

SURFFLASH(R) PLUS SAFETY I.V. CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

SURFLASH SAFETY I.V. CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

Terumo Pen Injector Needle 34

FDA 510(k)

FDA Class 2 ·General Hospital

OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SupaChair Powered Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP

FDA 510(k)

FDA Class 2 ·Physical Medicine

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTRODE FOR URINARY INCONTINENCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Essence 55SP Large Monitor System

FDA 510(k)

FDA Class 2 ·Cardiovascular

UBI MAGIWEL(TM) ANA QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology