Data / Medical devices / Israel / Pulsenmore Ltd
Pulsenmore Ltd: FDA-registered device maker in Omer Southern, Israel, 1 510(k) clearance
Pulsenmore Ltd is registered with the FDA (registration 3020542149) in Omer Southern, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020542149
- Address
- 8 Omarim St., Omer Southern, Israel, 8496500
- Owner or operator
- Pulsenmore LTD (10094113)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 15, 2025
- Registered through
- 2026
- Brand names listed
- Pulsenmore ES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ultrasound Imaging System For Acquiring Images At Home By Lay Users | SGJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 31, 2025 | DEN240074 | Pulsenmore ES | SGJ | Unknown | Pulsenmore, Ltd. | accessdata.fda.gov |
Updated October 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.