10,000 results · 52ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PULSAR/DISCOVERY/MERIDIAN

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·PEPGEN P-15/PEPGEN P-15 FLOW

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·INFUSE BONE GRAFT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/ITREL 3/SYNERGY/SYNERGY VERSITREL INS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM CRT-D9750 (ZL102)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval
FDA Class 3 ·Symplicity Spyral™ Renal Denervation System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella CP with SmartAssist

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DF-1 CONNECTOR PORT PIN PLUG,IS-1 CONNECTOR PORT PIN PLUG KIT,SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SUPARTZ

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval
FDA Class 3 ·PROGENSA PCA3 ASSAY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR