10,000 results · 50ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE TAG Thoracic Endoprosthesis

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure (LAAC) Device and Delivery System

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus and LIAISON Control QuantiFERON - TB Gold Plus

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CareLink Encore Programmer, CareLink Encore Programmer Head, CareLink SmartSync Device Manager Patient Connector, CareLi

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Algovita Spinal Cord Stimulation System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Biocor, Biocor Supra, Epic, Epic Supra

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·HV Splitter/Adaptor kit, Sprint Quattro Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·SOLETRA/KINETRA/ACTIVA PC/SC/RC

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB & ENDOAVITENE

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN ABILITY LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE PULSE GENERATOR AND PROGRAMMER

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT