Data / Medical devices / Monitor, Ultrasonic, Nonfetal
Monitor, Ultrasonic, Nonfetal (JAF): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Monitor, Ultrasonic, Nonfetal (product code JAF, Class 2, 21 CFR 892.1540). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on December 13, 2024, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JAF
- Device class
- 2
- Regulation
- 892.1540
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Italy | 2 |
| Japan | 1 |
| United Kingdom | 1 |
Makers of Monitor, Ultrasonic, Nonfetal
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| THD SPA | Correggio Reggio Emilia, Italy | Manufacturer | 3 | February 24, 2015 | 0 | 0 | 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 |
| Hadeco, Inc. | KAWASAKI Kanagawa, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huntleigh Healthcare Ltd. | Cardiff, South Glamorgan, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microlab Elettronica | Ponte S. Nicolo Padova, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 13, 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.