Data / Medical devices / Dilator, Cervical, Hygroscopic-Laminaria
Dilator, Cervical, Hygroscopic-Laminaria (HDY): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Dilator, Cervical, Hygroscopic-Laminaria (product code HDY, Class 2, 21 CFR 884.4260). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on January 18, 2005, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HDY
- Device class
- 2
- Regulation
- 884.4260
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 1 |
| India | 1 |
| Israel | 1 |
Makers of Dilator, Cervical, Hygroscopic-Laminaria
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 |
|---|---|---|---|---|---|---|---|---|
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer | 2 | June 14, 1989 | 0 | 0 | 0 | api.fda.gov |
| Degania Medical Devices Pvt. Ltd. | GURGAON Haryana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Degania Silicone, Ltd. | DEGANIA BET Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 18, 2005. 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.