10,000 results · 37ms · Sources: EU EUDAMED, US FDA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·BELOS VR-T

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity (comfilcon A) Toric Multifocal Soft (Hydrophilic) Extended Wear Contact Lenses

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,

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 ·VITA ENHANCR II

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK PATIENT MONITOR

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·CARDIOMESSENGER HOME MONITORING SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY

Implantable Pulse Generator, Pacemaker (Non-Crt)

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PROCINE BIOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT FAMILY OF LEADS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Sprint Quattro Lead 6946M; Sprint Quattro Lead 6935, 6935M, 6944, 6947, 6947M

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 700, KAPPA 900, ENPULSE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis, Models 305, 310

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Model 5071 Lead