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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HYDROVIEW IOLS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SUREFIX TM MODEL 5072 LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CYLOS DR, PROTOS DR-CLS, PHILOS 2 DR, PHILOS DR, AXIOS DR

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PRIZM & VITALITY FAMILIES OF ICDS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED PROGRAMMABLE INFUSION PUMPS

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM Masters HP Valved Graft

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous-Transluminal Angioplasty Balloon Catheter

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Durata and Optisure Leads (HV Active and Passive)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Llivia, Inlexa, Intica 7/5, VR-T/ DR-T DF4

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT Total PSA Reagent/Calibrator/Control Kit

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·LIBERTE OTW

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval
FDA Class 3 ·BSD-500 HYPERTHERMIA SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX INJECTABLE GEL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Revo MRI SureScan IPG

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400