10,000 results · 36ms · Sources: EU EUDAMED, US FDA

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·SECURE -C CERVICAL ARTIFICIAL DISC

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DURATA FAMILY OF LEADS

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·COLLAGRAFT STRIP BONE GRAFT MATRIX

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare HVAD System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·PhysioStim®, SpinalStim®

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX2 Endovascular AAA System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM VOLUMA XC

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval
FDA Class 3 ·MENTOR POLYTEF PASTE /FOR INJECTION

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-CORE-IGMK PLUS ASSAY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX CRT DEVICE & CARDIOMESSENGER II

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TREO® Abdominal Stent-Graft System

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SINGLE CHAMBER PACEMAKERS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·KELMAN(TM) OMNIFIT II MODEL 2100

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·VIBRANT SOUNDBRIDGE SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·XACT CAROTID STENT SYSTEM