10,000 results · 51ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ICD PUNCTUA VR IS4

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·XACT CAROTID STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CIBA VISION LOTRAFILCON B & A SOFT CONTACT LENSES

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT RP ENDOPROSTHESIS LLIAC

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL ORGINAL/SURGICEL FIBRILLAR/SURGICEL NU-KNIT ABSORABLE HEMOSTATS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT AXSYM AUSAB

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/ACCESSORIES/ACCESSORY KITS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER,