10,000 results · 38ms · Sources: EU EUDAMED, US FDA

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·TAPSYSTEM 2A

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DIPLOS MODEL 05 A & B

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval
FDA Class 3 ·GENESA(R) SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK-PLUS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Renamic Neo

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·PROTEGO DF-1 LEAD FAMILY

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·SOLETRA AND ITREL II NEUROSTIMULATORS FOR DEEP BRAIN STIMULATION (DBS) SOFTWARE

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

FDA Pre-Market Approval
FDA Class 3 ·Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 530G SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE LEAD, CAPSURE MODEL LEAD, PRODIGY IPG

Implantable Pacemaker Pulse-Generator

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

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX FAMILY OF ICD AND CRT-D

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROSTATRON

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN STARFIX LEAD