Data / Medical devices / Uterine Electromyographic Monitor
Uterine Electromyographic Monitor (OSP): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make Uterine Electromyographic Monitor (product code OSP, Class 2, 21 CFR 884.2720). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on September 18, 2020, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OSP
- Device class
- 2
- Regulation
- 884.2720
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 1 |
| India | 1 |
| China | 1 |
| Germany | 1 |
| United Kingdom | 1 |
Makers of Uterine Electromyographic Monitor
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 |
|---|---|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | Wauwatosa, WI, United States | Specification developer | 1 | August 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Datex-Ohmeda, Inc. | Waukesha, WI, United States | Specification developer | 1 | August 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 1 | August 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | August 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | BANGALORE Karnataka, India | Specification developer | 1 | August 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| China Qingdao Bright Medical Manufacturing Co.,ltd. | Qingdao Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tioga Limited | DERBY Derbyshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 18, 2020. 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.