177 results · 20ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

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

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE/COLLATAPE/COLLA[LUG ABSORBABLE COLLAGEN WOUND DRESS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA DBS LEAD, ACTIVA DBS LEAD REDUCED SPACING

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COLLASTAT/INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Pulse Geneerator, Permanent, Implantable

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Tupos LV/ATx and Kronos LV-T CRT-D System

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

FDA Pre-Market Approval
FDA Class 3 ·Stratos LV/LV-T CRT-P System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CryoConsole

Coronary Drug-Eluting Stent

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Coronary Drug-Eluting Stent

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

Heart-Valve, Mechanical

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

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Emblem Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, VERA, SENSIA IPG'S; ADVISA DR/DR MRI IPG'S