92 results · 24ms · Sources: EU EUDAMED, US FDA

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VIRTUOSO

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·CONCERTO

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CONCERTO II/CONSULTA/MAXIMO II CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 400 DR/SR IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEMA IPG/C & T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARELINK DDMA SOFTWARE AND CARELINK MONITOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·INSYNC CRT-P & INSYNC III CRT-P