715 results · 21ms · Sources: EU EUDAMED, US FDA

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·FLOSEAL MATRIX (AKA PROCEED) HEMOSTATIC SEALANT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel, Spinal Cord Stimulation Systems

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System (Bowel)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System (Urinary)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Anthem PM3210 NKE; Allure, Allure Quadra PM3120, PM3222, PM3140, PM3242; Quadra Allure MP PM3160, PM3262;

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·MENICON Z RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·MENICON Z

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS