612 results · 19ms · Sources: EU EUDAMED, US FDA

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval
FDA Class 3 ·Progensa PCA3 Assay

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRX AND VENTAK MINI SYSTEMS

Prostrate Cancer Genes Nucleic Acid Amplification Test System

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

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·REVEAL LINQ SOFTWARE MODEL SWO26

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Arista AH; Arista AH Absorbable Hemostat

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SELUTE PICOTIP STEROID ELUTING LEAD

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEL BREAST IMPLANT

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·COLOGUARD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM