Data / Medical devices / Transducer, Ultrasonic, Obstetric
Transducer, Ultrasonic, Obstetric (HGL): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Transducer, Ultrasonic, Obstetric (product code HGL, Class 2, 21 CFR 884.2960). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on July 18, 1995, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HGL
- Device class
- 2
- Regulation
- 884.2960
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 2 |
| United Kingdom | 1 |
| South Korea | 1 |
| China | 1 |
| Brazil | 1 |
Makers of Transducer, Ultrasonic, Obstetric
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 |
|---|---|---|---|---|---|---|---|---|
| Huntleigh Healthcare Ltd. | Cardiff, South Glamorgan, United Kingdom | Complaint file establishment, Manufacturer | 1 | June 28, 1993 | 0 | 0 | 0 | api.fda.gov |
| American I.V. Products, Inc. | Harmans, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B'orze Inc | Boise, ID, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bistos co., ltd. | Yongin-si Gyeonggi, South Korea | Complaint file establishment, 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 | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nicolay GMBH | NAGOLD Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parks Medical Electronics, Inc. | Aloha, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Ltda | Varginha Minas Gerais, Brazil | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 18, 1995. 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.