2,709 results · 19ms · Sources: EU EUDAMED, US FDA

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Monovisc

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Ophthalmic Viscoelastic

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMDOGAIN

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS

Organ Care System (Ocs) Heart System

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

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Device, Hemostasis, Vascular

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIOLINK VASCULAR CLOSURE SYSTEM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400

Tissue Graft Of 6mm And Greater

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Lotus Edge Valve System

Stent, Carotid

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

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Nuvisc, Anikavisc, Ophthalin

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity HPV Assay