48 results · 19ms · Sources: EU EUDAMED, US FDA

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SBL-3 Intraocular Lens

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SBL-3 Multifocal Intraocular Lens

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SBL-3 Multifocal Intraocular Lens

Prosthesis, Finger, Constrained, Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·COROX OTW (-S) BP STEROID-ELUTING LEADS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·COROX OTW (-S) BP LEFT VENTRICULAR LEADS

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL II ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL ARTERIAL CLOSURE SYSTEM WITH Q-FOAM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM