EBR Systems, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “EBR Systems, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SEG | Leadless Cardiac Resynchronization Therapy (Crt) | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240028 | PMA | WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System | 2025-04-11 |
Recalls
openFDA lists no recalls under a recalling firm named EBR Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named EBR Systems, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT06561932: A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT (Recruiting, started 2025-12-18)
- NCT07098858: The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry) (Recruiting, started 2025-11-03)
- NCT02922036: Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients (Active not recruiting, started 2018-01-17)
- NCT02610673: WiCS-LV Post Market Surveillance Registry (Active not recruiting, started 2016-02-08)
- NCT01905670: Safety and Performance of Electrodes Implanted in the Left Ventricle (Completed, started 2013-07)
SEC filings
EBR Systems, Inc. (EBRCZ): EDGAR filings, CIK 1347123. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under EBR Systems, Inc.?
FDA lists 0 510(k) clearances under the applicant name “EBR Systems, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under EBR Systems, Inc.?
The most frequent FDA product codes under this applicant name are SEG (Leadless Cardiac Resynchronization Therapy (Crt), 1).
Next steps
- See all 0 EBR Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SEG, EBR Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.