THERMOGARD THERMAL REGULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593

FDA 510(k)

FDA Class 2 ·Cardiovascular

ICY CATHETER, MODEL IC-3893A

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUATTRO CATHETER MODEL IC4593

FDA 510(k)

FDA Class 2 ·Cardiovascular

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D

FDA 510(k)

FDA Class 2 ·Cardiovascular

System, Hypothermia, Intravenous, Cooling

FDA classification

FDA Class 2 ·System, Hypothermia, Intravenous, Cooling

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

GRAFTCAGE ACX

FDA 510(k)

FDA Class 2 ·Orthopedic

Aveli

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Athena Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Willow Wearable Breast Pump 2.0

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACX RX COMET VP CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HARTZLER ACX II(R) CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS HARTZLER ACX II CORONARY DILATATION BALLOON CA

PTFE Super Sheath Introducer 2.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

C3 Wave

FDA 510(k)

FDA Class 2 ·General Hospital

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PercuNav Image Fusion and Interventional Navigation System

FDA 510(k)

FDA Class 2 ·Radiology