2,317 results · 19ms · Sources: EU EUDAMED, US FDA

Pump, Infusion, Implanted, Programmable

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

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Implanted Fecal Incontinence Device

FDA Pre-Market Approval
FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER

Transcatheter Septal Occluder

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

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems

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 ·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