10,000 results · 463ms · Sources: EU EUDAMED, US FDA

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Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE Z NOVUS

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval
FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta, Viva Quad MRI CRT-D

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ReShape Lap-Band System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards Commander Delivery System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™),

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards Commander Delivery System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TELIGEN/INCEPTA/ENERGEN/PUNCTUA/CONFIENT ICDS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane and Perlane

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM