Data / Medical devices / United States / Annabella Technologies Inc.
Annabella Technologies Inc.: FDA-registered device maker in N Palm Beach, FL, United States, 2 510(k) clearances
Annabella Technologies Inc. is registered with the FDA (registration 3031841858) in N Palm Beach, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3031841858
- Address
- 4440 Pga Blvd Ste 600, N Palm Beach, FL, United States, 33410
- Owner or operator
- Annabella Tech (10088803)
- Roles
- Complaint file establishment
- First device listed
- October 12, 2023
- Registered through
- 2026
- Brand names listed
- Annabella Breast Pump, Annabella Double Breast Pump
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| June 27, 2024 | K241506 | Annabella Double Breast Pump (ADO-US23-1000) | HGX | Substantially Equivalent | Annabella Tech | accessdata.fda.gov |
| August 4, 2023 | K230672 | Annabella Breast Pump | HGX | Substantially Equivalent | Annabella , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 27, 2024. 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.