Data / Medical devices / Media, Coupling, Ultrasound
Media, Coupling, Ultrasound (MUI): 15 FDA-registered makers in 7 countries
15 establishments in 7 countries are registered with the FDA to make Media, Coupling, Ultrasound (product code MUI, Class 2, 21 CFR 892.1570). 12 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on June 17, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- MUI
- Device class
- 2
- Regulation
- 892.1570
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| United States | 4 |
| Austria | 2 |
| South Korea | 1 |
| Canada | 1 |
| Turkey | 1 |
| Israel | 1 |
Makers of Media, Coupling, Ultrasound
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 |
|---|---|---|---|---|---|---|---|---|
| Sheathing Technologies, Inc. | Morgan Hill, CA, United States | Manufacturer | 2 | February 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer | 1 | October 25, 2017 | 0 | 1 | 0 | api.fda.gov |
| Anhui Deepblue Medical Technology Co., Ltd. | Hefei Anhui, China | Manufacturer | 1 | September 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Edgecare Inc. | Yeongdeungpo-gu Seoul, South Korea | Manufacturer | 1 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Foshan Pingchuang Medical Technology Co., Ltd | Foshan City Guangdong, China | Manufacturer | 1 | June 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hony Medical Co., Ltd | Taishan Guangdong, China | Contract manufacturer, Manufacturer | 1 | July 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| HR PHARMACEUTICALS, INC d/b/a HR HealthCare | York, PA, United States | Manufacturer | 1 | June 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Jianerkang Medical Co., Ltd. | Changzhou City Jiangsu, China | Manufacturer | 1 | December 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| National Therapy Products Inc. | Brampton Ontario, Canada | Manufacturer | 1 | February 25, 2002 | 0 | 0 | 0 | api.fda.gov |
| Parker Laboratories, Inc. | Fairfield, NJ, United States | Manufacturer | 1 | April 16, 1982 | 0 | 0 | 0 | api.fda.gov |
| Safersonic Medizinprodukte Handelsges.m.b.h | Persenbeug Niederosterreich, Austria | Exporter to the US, Specification developer | 1 | October 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun | ESENYURT Istanbul, Turkey | Manufacturer | 1 | June 18, 2014 | 0 | 1 | 0 | api.fda.gov |
| Ming Fai Industrial (shenzhen) Co. Ltd. | SHENZHEN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmasept Ltd. Medical Products | Caesarea Central, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmazeutische Fabrik Montavit Ges.m.b.h. | Absam Tirol, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 17, 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.