Data / Medical devices / Monitor, Ultrasonic, Fetal
Monitor, Ultrasonic, Fetal (KNG): 19 FDA-registered makers in 4 countries
19 establishments in 4 countries are registered with the FDA to make Monitor, Ultrasonic, Fetal (product code KNG, Class 2, 21 CFR 884.2660). 17 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 60 510(k) clearances under this code, the latest on January 8, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KNG
- Device class
- 2
- Regulation
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| China | 11 |
| United States | 6 |
| United Kingdom | 1 |
| Israel | 1 |
Makers of Monitor, Ultrasonic, Fetal
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 |
|---|---|---|---|---|---|---|---|---|
| Contec Medical Systems Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 3 | June 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 3 | June 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 2 | October 27, 2011 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 2 | January 3, 2003 | 0 | 1 | 0 | api.fda.gov |
| Huntleigh Healthcare Ltd. | Cardiff, South Glamorgan, United Kingdom | Complaint file establishment, Manufacturer | 2 | June 24, 1994 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Bestman Instrument Co.,ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 2 | June 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Jumper Medical Equipment Co.,Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | January 24, 2014 | 0 | 0 | 0 | api.fda.gov |
| B'orze Inc | Boise, ID, United States | Specification developer | 1 | March 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Heramed Ltd. | Netanya Central, Israel | Manufacturer | 1 | November 14, 2019 | 0 | 0 | 0 | api.fda.gov |
| Imex, LLC | Fulton, MD, United States | Manufacturer | 1 | July 2, 1990 | 0 | 0 | 0 | api.fda.gov |
| Ninghai Guangjie Electronic Commerce Co., Ltd | Ningbo Zhejiang, China | Manufacturer | 1 | December 11, 1992 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Imdk Medical Technology Co., Ltd. | SHENZHEN Guangdong, China | Manufacturer | 1 | July 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Jamr Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | June 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Taikang Medical Equipment Co.,ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | January 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | May 21, 2010 | 0 | 0 | 0 | api.fda.gov |
| Vcomin Technology Limited | Shenzhen Guangdong, China | Manufacturer | 1 | May 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Zhongshan Xiaolan Town Senlan Electronic Factory | Zhongshan City Guangdong, China | Manufacturer | 1 | January 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 8, 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.