1,331 results · 21ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare HVAD System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·CentriMag Circulatory Support System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3037A FUNCTION PACK

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTMATE II VENTRICULAR ASSISTE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory 5816, 5810, 5610; Zephyr 5820, 5826, 5620, 5626; Accent PM1110, PM1210, PM2110, PM2210; Assurity PM1240, PM2240;

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare HVAD System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart