Data / Medical devices / Spatula, Cervical, Cytological / United States
FDA-registered makers of Spatula, Cervical, Cytological in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Spatula, Cervical, Cytological (product code HHT). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Spatula, Cervical, Cytological
- Product code
- HHT
- Country
- United States
Makers of Spatula, Cervical, Cytological in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Repackager or relabeler | 5 | January 4, 1990 | 0 | 0 | 0 | api.fda.gov |
| Andwin Scientific | Simi Valley, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 4 | November 16, 1998 | 0 | 0 | 0 | api.fda.gov |
| Cordica Medical, Inc. | Morristown, TN, United States | Contract manufacturer, Manufacturer | 1 | July 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Specification developer | 1 | September 10, 1990 | 0 | 0 | 0 | api.fda.gov |
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer, Specification developer | 1 | May 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| Medical Packaging Corporation | Camarillo, CA, United States | Manufacturer | 1 | January 9, 1987 | 0 | 0 | 0 | api.fda.gov |
| Puritan Medical Products Company LLC | Guilford, ME, United States | Repackager or relabeler, Specification developer | 1 | January 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| Qiagen | Germantown, MD, United States | Manufacturer | 1 | September 19, 1997 | 0 | 0 | 0 | api.fda.gov |
| Advanced Engineering, Inc. | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.