417 results · 27ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·SmartAblate System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, ENERGEN

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip System (NT)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator (WCD) System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

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

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SCULPTRA and SCULPTRA Aesthetic (injectable poly-L Lactic acid)

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM

Processor, Cervical Cytology Slide, Automated

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+/CAPSURE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX LEAD & REVO MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN STARFIX LEAD