10,000 results · 43ms · Sources: EU EUDAMED, US FDA

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Mentor MemoryShape Silicone Gel-Filled Breast Implants

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS AUDITORY BRAINSTEM IMPLANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Dexom G4 PLATINUM Continuous Glucose Monitoring System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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

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

FDA Pre-Market Approval
FDA Class 3 ·Wolverine Coronary Cutting Balloon

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE 1.3CC AND 0.3CC

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-ABSORBING ONE-PIECE PMMA ANTERIOR CHAMBER IOL

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Express SD Renal Monorail Premounted Stent System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·ANIMAS VIBE SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CCT.2 CRYOABLATION CONSOLE SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Lotrafilcon A and Lotrafilcon B Soft Contact Lenses

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-ABSORBING PMMA ANTERIOR CHAMBER IOLS

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·MBT TIBIAL TRAY

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY RX ZOTAROLIMUS ELUTING CORONARY SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE