70 results · 17ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EBI BONE HEALING SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS MODELS OF SLX LEADS AND VARIOUS MODELS OF SELOX,DEXTRUS,AND SAFIO DRUG ELUTING LEADS

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System, WATCHMAN Left Atrial Appendage (LAA) Closure Te

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ENTOVIS, EVIA, ESTELLA, EFFECTA, ECURO, DEXTRUS, SETROX, SELOX, TILDA, P-KIT, SAFIO, SLX, CARDIOMESSENGER LLT KIT, ICS

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·QCELLUS LASER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD