Is this your brand? Sign in to claim ownership.
Sign in to claim this brandNatus Medical, Inc.
US
Last updated May 30, 2026
What Natus Medical, Inc. makes
Natus Medical produces ophthalmic imaging devices, including the RetCam series for retinal photography in newborns and infants, as well as portable and shuttle versions for clinical and field use. The company also manufactures phototherapy units, such as the Natus Blue Light Phototherapy Unit and NeoBlue Cozy LED system, designed for neonatal jaundice treatment. Auditory screening tools like the Algo series (including Algo 2, Algo 3, and Algo 3i) are used for newborn hearing assessments, while the Minimuffs provide ear protection for infants. Additionally, the company offers neonatal monitoring solutions like the Olympic BrainZ Monitor and end-tidal breath analyzers, such as the Co-Stat.
These devices are regulated under FDA classifications, including Class II and Class U (unclassified), with authorisations granted through the 510(k) pathway and the FDA’s Unique Device Identification (UDI) system. The company’s products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device regulations. Natus Medical operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- retcam.com
- —
- —
- [email protected]
- Phone
- +1 650-802-0400
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080517260
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RetCam 3 | RetCam 3 | FDA UDI | Class II | Active |
| RetCam Portable | RetCam Portable | FDA UDI | Class II | Active |
| RetCam Shuttle | RetCam Shuttle | FDA UDI | Class II | Active |
| Natus Blue Light Phototherapy Unit | K022196 | FDA 510(k) | Class II | Active |
| Olympic Brainz Monitor Model Obm70001 | K093949 | FDA 510(k) | Class II | Active |
| Algo 3 Newborn Hearing Screener | K013137 | FDA 510(k) | Class II | Active |
| Algo 3i Newborn Hearing Screener | K030823 | FDA 510(k) | Class II | Active |
| Minimuffs | K935160 | FDA 510(k) | U | Active |
| Neoblue Cozy Led Phototherapy System | K051869 | FDA 510(k) | Class II | Active |
| Co-Stat(tm) End Tidal Breath Analyzer | K974805 | FDA 510(k) | Class II | Active |
| Algo 5 Newborn Hearing Screener | K073665 | FDA 510(k) | Class II | Active |
| Algo-2 Newborn Hearing Screener | K936039 | FDA 510(k) | Class II | Active |
| Natus Neuroworks, Model 104196 | K090019 | FDA 510(k) | Class II | Active |
| Navigator Pro With Aep Software (biomark, Enog, Champ) | K083371 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Natus Medical, Inc. has two recall records, both initiated in 2005 and 2010, respectively on June 27, 2005, and June 4, 2010. Both recalls were subsequently terminated. The first involved SonaMed Clarity devices due to insufficient evidence supporting claims for safety and efficacy, while the second concerned Preamp cable assemblies that had not been properly tested, which could lead to potential shock.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 4, 2010 | Z-2165-2010 | — | terminated | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. |
| Jun 27, 2005 | Z-0985-05 | — | terminated | Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users. |