J-TIP INJECTOR SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Wiygul Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMIG-MRI

FDA 510(k)

FDA Class 2 ·Radiology

CENTRAL VENOUS CATHETER W/BIG-GARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC MONORAIL/NC BIG RANGER/NC RANGER PTCA CATHETHERS

Philips CT Big Bore Sliding Gantry Configuration

FDA 510(k)

FDA Class 2 ·Radiology

SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OR SPECIFIC BIG CASE BACK TABLE COVER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30

FDA 510(k)

FDA Class 2 ·Cardiovascular

GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEBP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·(POLYMACON) CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS