Data / Medical devices / Spatula, Cervical, Cytological
Spatula, Cervical, Cytological (HHT): 14 FDA-registered makers in 5 countries
14 establishments in 5 countries are registered with the FDA to make Spatula, Cervical, Cytological (product code HHT, Class 2, 21 CFR 884.4530). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 73 510(k) clearances under this code, the latest on April 25, 2019, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- HHT
- Device class
- 2
- Regulation
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Netherlands | 1 |
| Brazil | 1 |
| Taiwan | 1 |
| China | 1 |
Makers of Spatula, Cervical, Cytological
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 |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Repackager or relabeler | 5 | January 4, 1990 | 0 | 0 | 0 | api.fda.gov |
| Rovers Medical Devices B.V. | OSS Noord-Brabant, Netherlands | Manufacturer | 5 | February 2, 2005 | 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 |
| Kolplast Ci Ltda | Itupeva Sao Paulo, Brazil | Manufacturer | 1 | January 13, 2017 | 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 |
| North Eos Industries, Inc. | Taichung City, Taiwan | Manufacturer | 1 | October 11, 1996 | 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 | |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang, Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 25, 2019. 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.