CONTOUR I V3.1 SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SofWave System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SofWave System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCIZER (SC1-M410)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIPSONIX(R) SYSTEM MODEL 2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NOSOGARD FILTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRASHAPE POWER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse ICD Devices

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN THRANSCATHETER HEART VALVE (THV)

SUMMIT MEDICAL

FDA UDI

Summit Medical, Inc.·00385640049313·

N/A

FDA UDI

SHIPPERT MEDICAL TECHNOLOGIES, INC·00812185033632·

SUMMIT MEDICAL

FDA UDI

Summit Medical, Inc.·00385640059022·

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)

FDA Pre-Market Approval

INOGEN, ORIGEN AND DYNAGEN CRT-DS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INOGEN, ORIGEN AND DYNAGEN ICDS