TEMPORARY PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TB SERIES BIPOLAR PACING LEADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·REVOLUTIONS (TM) ALT. MANU. SITE CONTACTS

MYRIAN

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

STERISPINE PS

FDA 510(k)

FDA Class 2 ·Orthopedic

OSSIX BONE

FDA 510(k)

FDA Class 2 ·Dental

OSSIX VOLUMAX

FDA 510(k)

FDA Class 2 ·Dental

OSSIX PLUS

FDA 510(k)

FDA Class 2 ·Dental

OSSIX Breeze

FDA 510(k)

FDA Class 2 ·Dental

MANDOMETER III

FDA 510(k)

FDA Class 2 ·Neurology

Vecttor VT-300

FDA 510(k)

FDA Class 2 ·Neurology

BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CINA-VCF

FDA 510(k)

FDA Class 2 ·Radiology

CINA-ASPECTS

FDA 510(k)

FDA Class 2 ·Radiology