Data / Medical devices / Monitor, Blood-Flow, Ultrasonic
Monitor, Blood-Flow, Ultrasonic (HEP): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Monitor, Blood-Flow, Ultrasonic (product code HEP, Class 2, 21 CFR 884.2660). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on August 10, 2010, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HEP
- Device class
- 2
- Regulation
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| South Korea | 1 |
| China | 1 |
Makers of Monitor, Blood-Flow, Ultrasonic
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 |
|---|---|---|---|---|---|---|---|---|
| Bionet Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 1 | March 3, 2003 | 0 | 0 | 0 | api.fda.gov |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 1 | August 10, 2010 | 0 | 0 | 0 | api.fda.gov |
| Natus Neurology Incorporated | Middleton, WI, United States | Complaint file establishment, Manufacturer | 1 | June 24, 1991 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 10, 2010. 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.