4,612 results · 30ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000 XP RF ABLATION SYSTEMS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Cardiva VASCADE Family

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·4Kscore Test

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE NANO AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·Integra® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim DRG Systems

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESIS, MODEL 7000 AND 7000TFX

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity DBS Systems

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx (F1CDx)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EBI BONE HEALING SYSTEM(R)

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM