10,000 results · 38ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES (IOLS)

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval
FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODAL VH8500

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·MICROFIBRILLAR COLLAGEN HEMOSTAT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HC2 SYSTEM SOFTWARE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE PERMANENT BIRTH CONTROL SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·KREMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL JM19UB POSTERIOR CHAMBER IOL

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PSW 1704.U

Stent, Central Venous

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT ENDOPROSTHESIS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR RMT THERMOCOOL CATHETER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PSW 1801.U

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SELECTSECURE LEAD MODEL 3830

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Programmer System