# Farapulse Inc

> Medical device manufacturer record on deviCERTS, compiled from public registries. Farapulse Inc is a medical device manufacturer based in the United States, with 14 devices listed in EUDAMED and FDA PMA (EU Class IIb and III; FDA Class III) as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/farapulse-inc>
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED
- EUDAMED SRN: US-MF-000017969

## Figures

- Devices: 14
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 13, FDA PMA 1
- Device classes: EU Class IIb 10, EU Class III 3, FDA Class III 1
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 9 devices
- EMDN [C02 Arrhythmology devices](https://devicerts.com/categories/emdn/C02): 3 devices
- EMDN [C05 Cardiovascular introducer sheaths](https://devicerts.com/categories/emdn/C05): 1 devices

## Sites and related companies

- Authorised representative: [ICON (LR) Limited](https://devicerts.com/representatives/icon-lr-limited-ie-ar-000006507) (Ireland)

## Devices

The first 14 of 14, in the order of the canonical page, which lists them all.

- [Faradrive™](https://devicerts.com/devices/faradrive-21m402) · ref 21M402 · Class III · EUDAMED · status: Active
- [Farastar™](https://devicerts.com/devices/farastar-m004pfce61m400) · ref M004PFCE61M400 · Class IIb · EUDAMED · status: Active
- [Farastar™](https://devicerts.com/devices/farastar-61m410) · ref 61M410 · Class IIb · EUDAMED · status: Active
- [Farastar™](https://devicerts.com/devices/farastar-61m411) · ref 61M411 · Class IIb · EUDAMED · status: Active
- [Farastar](https://devicerts.com/devices/farastar-61m407) · ref 61M407 · Class IIb · EUDAMED · status: Active
- [Farastar™](https://devicerts.com/devices/farastar-61m409) · ref 61M409 · Class IIb · EUDAMED · status: Active
- [Farastar](https://devicerts.com/devices/farastar-41m404) · ref 41M404 · Class III · EUDAMED · status: Active
- [Farastar™](https://devicerts.com/devices/farastar-61m405) · ref 61M405 · Class IIb · EUDAMED · status: Active
- [Farastar](https://devicerts.com/devices/farastar-61m401) · ref 61M401 · Class IIb · EUDAMED · status: Active
- [Farastar™](https://devicerts.com/devices/farastar-61m415) · ref 61M415 · Class IIb · EUDAMED · status: Active
- [Farawave™](https://devicerts.com/devices/farawave-41m401) · ref 41M401 · Class III · EUDAMED · status: Active
- [Farastar™](https://devicerts.com/devices/farastar-61m404) · ref 61M404 · Class IIb · EUDAMED · status: Active
- [FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)](https://devicerts.com/devices/farapulse-pulsed-field-ablation-system-farawave-pulsed-field-p230030) · ref P230030 · Class III · PMA · status: Active · decision 2024-01-30 · open recall
- [Farastar™](https://devicerts.com/devices/farastar-61m417) · ref 61M417 · Class IIb · EUDAMED · status: Active

## Source and citation

- Cite as: Farapulse Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/farapulse-inc (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA PMA](https://open.fda.gov/apis/device/pma/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/farapulse-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/farapulse-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.