preCARDIA Occlusion System

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Impella XR Sheath Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPELLA CONTROLLER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABIODENT PERIOTEMP(R) SYSTEM

FDA 510(k)

FDA Class 1 ·Dental

Abiomed 14Fr Low Profile Introducer Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPELLA 2.5 PLUS CATHETER

FDA 510(k)

SUPRACOR BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Impella CP Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABIOMED BODY LEAD ANALYZER MODEL 200/20

FDA 510(k)

FDA Class 2 ·Radiology

IMPELLA CONTROLLER WITH FLOW CONTROL

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPELLA 5.0 CATHETER FAMILY

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXY-1 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXY-1 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED ARTERIAL CANNULA

Abiomed Breethe OXY-1 System

FDA UDI

Breethe, Inc.·00813502012361·OXY-1 Console Intake Filter Qty 5

Abiomed Breethe OXY-1 System

FDA UDI

Breethe, Inc.·00813502013184·TUBING INSULATOR KIT

Abiomed Breethe OXY-1 System

FDA UDI

Breethe, Inc.·10860001797920·Condensation Tray Pouch Assembly

Abiomed Breethe OXY-1 System

FDA UDI

Breethe, Inc.·00813502012354·OXY-1 Condensate Tray Qty 5