Data / Medical devices / Monitor, Ultrasonic, Nonfetal / United States
FDA-registered makers of Monitor, Ultrasonic, Nonfetal in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Monitor, Ultrasonic, Nonfetal (product code JAF). 5 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
- Monitor, Ultrasonic, Nonfetal
- Product code
- JAF
- Country
- United States
Makers of Monitor, Ultrasonic, Nonfetal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Natus Neurology Incorporated | Middleton, WI, United States | Manufacturer | 4 | March 9, 2001 | 0 | 1 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 2 | December 24, 2009 | 0 | 0 | 0 | api.fda.gov |
| Imex, LLC | Fulton, MD, United States | Manufacturer | 2 | August 7, 1998 | 0 | 0 | 0 | api.fda.gov |
| Newman Medical | Arvada, CO, United States | Manufacturer | 1 | May 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Unetixs Vascular, Inc. | Warwick, RI, United States | Manufacturer | 1 | April 29, 1991 | 0 | 1 | 0 | api.fda.gov |
| Surgical Technologies, Inc. | St. Paul, MN, 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.