10,000 results · 35ms · Sources: EU EUDAMED, US FDA

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter, In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Attain StarFix Lead

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra TPS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK PATIENT MONITOR, MYCARELINK READER FRU

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

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

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS MODELS OF PHILOS/AXIOS/PROTOS/CYLOS PG'S

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

FDA Pre-Market Approval
FDA Class 3 ·NEXGEM LPS-FLEX MOBILE AND LPS-MOBILE KNEES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX MRI LEAD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System

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

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·LIAISON QuantiFERON-TB Gold Plus

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-EBK PLUS Assay