2,762 results · 22ms · Sources: EU EUDAMED, US FDA

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC(HYLAN G-F 20)

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Bulkamid Urethral Bulking System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENROUTE Transcarotid Stent System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·AED 3 defibrillator

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INFUSAID REFILL KIT

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Liver

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

FDA Pre-Market Approval
FDA Class 3 ·HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Series Product Line and the Ynaflex Inflatable Penile Prostheses

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Cervista HPV HR Assay

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Heart-Valve, Mechanical

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

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·ThinPrep Integrated Imager