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

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra Transcatheter Pacing System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·In.Pact Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Chatheter

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra Transcatheter Pacing System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Device, Hemostasis, Vascular

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·TRIFECTA VALVE

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·FLOSEAL Hemostatic Matrix/ Floseal Special Applicator Tips

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·Artegraft Collagen Vascular Graft

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENTS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·EON MINI, PROTEGE, IPG PROTEGE 3.01, IPG PROTEGE MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 SYSTEM