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

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra AV TPS, Micra TPS

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL SNoW™ Absorbable Hemostat

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE EPI EPICARDIAL STEROID ELUTING PACING LEAD

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve™ EnVeo™ R Loading System, Medtronic CoreValve™ EnVeo™ Pro Loading System, Medtronic Evolut™ Pro+ Loa

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic EnVeo R Delivery Catheter System, Medtronic EnVeo PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·WEB Aneurysm Embolization System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT)

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS); PROGEL Spare Tips accessory; PROGEL 6 Extended Tips accessory; PROGEL 11 Extende

Stent, Coronary

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

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·MOBILE PROSTATRON

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5, Impella CP, Impelia CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Epsila EV Extravascular Lead (EV2401)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 400

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED™ Absorbable Adhesion Barrier

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN OTW/ATTAIN LV LEAD/ATTAIN CS LEAD

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

Placental Alpha Microglobulin-1 Immunoassay

FDA Pre-Market Approval
FDA Class 3 ·PartoSure Test