10,000 results · 33ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEMA FAMILIES/C & T SERIES DEVICES

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ARCHITECT FREE PSA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DISCOVERY/ MERIDIAN

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD PREPSTAIN SYSTEM

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·BLU-U

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX OTW BARE-METAL CORONARY STENT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE

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

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·PERFLURON

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Coronary Drug-Eluting Stent

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCULAR SOLUTIONS DUETT SEALING DEVICE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·POSTERIOR CHAMBER MONOFOCAL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY XR