Data / Medical devices / Monitor, Uterine Contraction, External (For Use In Clinic)
Monitor, Uterine Contraction, External (For Use In Clinic) (HFM): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Monitor, Uterine Contraction, External (For Use In Clinic) (product code HFM, Class 2, 21 CFR 884.2720). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on May 29, 2014, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HFM
- Device class
- 2
- Regulation
- 884.2720
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 2 |
| India | 2 |
| China | 1 |
| Brazil | 1 |
Makers of Monitor, Uterine Contraction, External (For Use In Clinic)
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 |
|---|---|---|---|---|---|---|---|---|
| American I.V. Products, Inc. | Harmans, MD, United States | Manufacturer | 1 | September 14, 2004 | 0 | 0 | 0 | api.fda.gov |
| Clinical Innovations, LLC | Murray, UT, United States | Complaint file establishment, Manufacturer | 1 | May 29, 2014 | 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 | |
| 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 | |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | BANGALORE Karnataka, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro GE Healthcare Private Ltd. | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 29, 2014. 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.