Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SLIDER (TM)3.4F LONG BALLOON DILATATION PTCA CATH

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX FLOWTRACK LONG(TM) CORONARY DILATATION CATH

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·3.4F SYNERGY(TM) II LONG BALL. DILATATION CATHETER

MERIDIAN-II AND MERDIAN-PLUS

FDA 510(k)

FDA Class 2 ·Neurology

MAX PULSE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CUBESCAN / BIOCON-700

FDA 510(k)

FDA Class 2 ·Radiology

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ABR-2000

FDA 510(k)

FDA Class 2 ·Neurology

MERIDIAN-PORTABLE

FDA 510(k)

FDA Class 2 ·Neurology

Chaorum Implant System

FDA 510(k)

FDA Class 2 ·Dental

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORE-CLIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Estar-Z

FDA 510(k)

FDA Class 2 ·Dental

PESSARY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ECG Cable/Leadwires

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORE-SNARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Surgical Gown (Sterile); Surgical Gown (Non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CORE-SPORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORE-Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology