FDA Device Database
FDA-Cleared Arrhythmia Devices
Comprehensive database of FDA-cleared cardiac rhythm management devices including PFA systems, ICMs, wearables, pacemakers, and ablation technology.
24
Devices Listed
4
PFA Systems
4
ICM Devices
4
Wearables
Device data sourced from FDA.gov public databases. Verify current status directly with manufacturers. This database is for informational purposes only.
Showing 24 devices
Varipulse™ Pulsed Field Ablation System
Variable-loop PFA catheter integrated with CARTO 3 mapping system for anatomically guided ablation.
Affera™ Mapping and Ablation System
Combines high-density mapping with pulsed field ablation and radiofrequency energy in a single catheter system.
CARTO® 3 V7 Mapping System
Industry-leading electroanatomical mapping platform with advanced visualization.
FARAPULSE™ Pulsed Field Ablation System
Pulsed field ablation system using pentaspline catheter design. Over 200,000 patients treated globally.
PulseSelect™ Pulsed Field Ablation System
First FDA-approved pulsed field ablation system. Uses non-thermal energy to create lesions in cardiac tissue while preserving surrounding structures.
AVEIR™ DR Leadless Pacemaker System
World's first dual-chamber leadless pacemaker with i2i (implant-to-implant) communication.
LINQ II™ Insertable Cardiac Monitor
Miniaturized insertable cardiac monitor with 4.5+ year battery life and smartphone connectivity.
Micra™ AV Leadless Pacemaker
Leadless pacemaker with AV synchronous pacing capabilities via accelerometer sensing.
KardiaMobile 6L
Personal 6-lead ECG device that provides clinical-grade readings via smartphone.
EMBLEM™ MRI S-ICD System
Subcutaneous ICD with full MRI compatibility - no transvenous leads.
Zio® XT Patch
Single-use adhesive patch monitor with AI-powered arrhythmia detection and analysis.
Apple Watch ECG
First FDA-cleared ECG in a consumer wearable. Single-lead ECG via Digital Crown electrode.
EnSite™ X EP System
EP mapping system with omnipolar technology for direction-independent signals.
TactiFlex™ Ablation Catheter
Contact force-sensing irrigated ablation catheter with flexible tip design.
RHYTHMIA HDx™ Mapping System
Ultra-high-density mapping with automated annotation and continuous map updates.
LUX-Dx™ Insertable Cardiac Monitor
ICM with wireless charging capability and up to 5+ years of continuous monitoring.
EXCELSIUS Lead Management Controller
Motorized controller for laser and mechanical lead extraction procedures.
KardiaMobile Card
Credit card-sized personal ECG device with instant smartphone transmission.
Azure™ MRI Pacemaker
Bluetooth-enabled pacemaker with MRI SureScan technology for safe MRI scans.
BioMonitor III
Insertable cardiac monitor with automated AF detection and daily ECG transmission.
THERMOCOOL SMARTTOUCH® SF
Surround flow irrigated tip catheter with contact force technology.
Confirm Rx™ Insertable Cardiac Monitor
World's first smartphone-compatible ICM with SharpSense R-wave detection technology.
Evera MRI™ ICD
MRI-safe ICD with SmartShock technology to reduce inappropriate shocks.
TightRail™ Rotating Dilator Sheath
Mechanical rotating dilator sheath for transvenous lead extraction.
Verified FDA Data Sources
All device information is sourced from official FDA databases. FDA numbers, clearance dates, and indications are verified against public records.