RX CBG

FDA 510(k)

FDA Class 2 ·Dental

BIG PHIL

FDA 510(k)

FDA Class 2 ·General Hospital

BIG BEN

FDA 510(k)

FDA Class 2 ·Cardiovascular

TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

CBG CUFF MANOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC BIB RANGER PTCA CATHETER

Philips CT Big Bore

FDA 510(k)

FDA Class 2 ·Radiology

MEGA BIG BOY CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sleepio®

FDA 510(k)

FDA Class 2 ·Neurology

DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.

FDA 510(k)

FDA Class 2 ·Cardiovascular

Daylight

FDA 510(k)

FDA Class 2 ·Neurology

CINtec Histology (50 tests), CINtec Histology (250 tests)

FDA 510(k)

FDA Class 2 ·Pathology

CINtec Histology

FDA 510(k)

FDA Class 2 ·Pathology

MP3HD BIG BOY, POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

THE BIG EASY Y-ADAPTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIG BAG 3000 PRESSURE INFUSOR

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC BIG RANGER PTCA CATHETER

Wiygul Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LEONI ORION System

FDA 510(k)

FDA Class 2 ·Radiology

CUFF BARO GUARD OR CBG ABBREVIATED

FDA 510(k)

FDA Class 2 ·Anesthesiology