Data / Medical devices / Oximeter / Israel
FDA-registered makers of Oximeter in Israel: 11 establishments
11 establishments in Israel are registered with the FDA to make Oximeter (product code DQA). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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Makers of Oximeter in Israel
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biobeat Technologies Ltd | Petakh Tikva Central, Israel | Exporter to the US, Manufacturer, Specification developer | 4 | December 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| S.L.P. Ltd. | Tel-Aviv Tel Aviv, Israel | Manufacturer, Repackager or relabeler | 3 | April 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare - Aviv | Tel Aviv, Israel | Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | March 7, 2002 | 0 | 0 | 0 | api.fda.gov |
| Orsense Ltd | Tel Aviv Yafo Central, Israel | Manufacturer | 1 | January 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| B.Y. Medimor Ltd | Tiberias Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CPC Solutions | Karmiel Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dormotech Medical Ltd. | Afula Northern, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nonagon Ltd. | Caesarea Haifa, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oridion Medical 1987 Ltd. | Jerusalem, Israel | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Sanmina- Sci Israel Medical Systems Ltd. | Maalot-Tarshiha Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Usr Electronic Systems (1987) Ltd | Karmiel Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.