Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-

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 (

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilesto 7 VR-T; Iforia 7 VR-T; Ilesto 5 VR-T; Iforia 5 VR-T; Ilesto 7 VR T DX; Iforia 7 VR-T DX; Ilesto 5 VR-T DX; Iforia

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T, In

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T

DHS Hungary Kft.

Importer

🇭🇺 Hungary·1 Manufacturer

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ISOFLEX S PERMANENT PACING LEAD MODELS PASSIVE PLUS DX

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T

170726773

Certificate

MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·8 Basic UDI-DIs

059786 MR2 170726773

Certificate

MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs