Data / Medical devices / Unit, Neonatal Phototherapy / United States
FDA-registered makers of Unit, Neonatal Phototherapy in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Unit, Neonatal Phototherapy (product code LBI). 8 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Unit, Neonatal Phototherapy
- Product code
- LBI
- Country
- United States
Makers of Unit, Neonatal Phototherapy in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | Wauwatosa, WI, United States | Specification developer | 3 | June 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Datex-Ohmeda, Inc. | Waukesha, WI, United States | Specification developer | 3 | June 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Lumitex Medical Devices, Inc. | Brecksville, OH, United States | Complaint file establishment, Manufacturer | 2 | June 8, 2012 | 0 | 1 | 0 | api.fda.gov |
| Draeger Medical Systems, Inc. | Telford, PA, United States | Repackager or relabeler, Specification developer | 1 | May 1, 2018 | 0 | 1 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 1 | June 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Little Sparrows Technologies Inc | Woburn, MA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 1 | September 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Neolight, LLC | Scottsdale, AZ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Replacement Parts Industries, Inc. | Simi Valley, CA, United States | Repackager or relabeler, Specification developer | 1 | May 31, 2002 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer for export, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | 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.