Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS, MODELS 6625L AND 6625-ESR-LP

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, MITRAL BIOPROSTHESIS,; BIOPROSTHESIS VALVED CONDUIT; DURAFLEX LOW PRES

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX, OptiSense, Tendril STS and Tendril ST Low Voltage Active Fixation Leads

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODEL# 6625LP AND 6625-ESR-LP

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LO

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve™ EnVeo™ R Loading System, Medtronic CoreValve™ EnVeo™ Pro Loading System, Medtronic Evolut™ Pro+ Loa

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification

FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Diagnostic Low Electric Field

FDA classification

FDA Class 3 ·Diagnostic Low Electric Field

Lipoprotein, Low Density, Removal

FDA classification

FDA Class 3 ·Lipoprotein, Low Density, Removal

Column, Adsorption, Low Density, Lipoprotein

FDA classification

FDA Class 3 ·Column, Adsorption, Low Density, Lipoprotein

Stimulator, Low Electric Field, Tumor Treatment

FDA classification

FDA Class 3 ·Stimulator, Low Electric Field, Tumor Treatment