46 results · 28ms · Sources: EU EUDAMED, US FDA

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SYNCRA CRT-P, CONSULTA CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MAXIMO II, PROTECTA, PROTECTA XT, SECURA VIRTUOSO II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ENRHYTHM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE FIREFLY (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE FIREFLY (PEDIATRIC)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·BSC CRV ENDOTAK LEADS

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·BSC Wolverine Coronary Cutting Balloon

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BSC Intella Nav MIFI OI Ablation Cathetrs

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE (BEHIND-THE-EAR) SYSTEM SENSOR (ADULT)

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP263) Assay

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·BSC WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System