Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·RECTAL THERMOSENSING UNIT RTU

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIC TARGIS SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR CORONARY SENT ON RX

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN Ultrasound Bone Healing System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

EXTENDED LIFE BATTERY

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Zilver PTX Drug-Eluting Peripheral Stent

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS; THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX TI

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER- EDWARDS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS BIOPROSTHESIS