Data / Medical devices / Ligator, Hemorrhoidal
Ligator, Hemorrhoidal (FHN): 61 FDA-registered makers in 15 countries
61 establishments in 15 countries are registered with the FDA to make Ligator, Hemorrhoidal (product code FHN, Class 2, 21 CFR 876.4400). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on June 6, 2022, and lists 4 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
- FHN
- Device class
- 2
- Regulation
- 876.4400
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 20 |
| China | 12 |
| Pakistan | 8 |
| Germany | 5 |
| United Kingdom | 2 |
| Italy | 2 |
| India | 2 |
| Canada | 2 |
| Mexico | 2 |
| Austria | 1 |
| Costa Rica | 1 |
| Ireland | 1 |
| South Korea | 1 |
| Belgium | 1 |
| Australia | 1 |
Makers of Ligator, Hemorrhoidal
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 |
|---|---|---|---|---|---|---|---|---|
| A.M.I. Agency For Medical Innovations GMBH | Feldkirch Vorarlberg, Austria | Manufacturer | 1 | June 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Beijing ZKSK Technology Co., Ltd. | beijing, China | Manufacturer | 1 | June 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Haemoband Surgical Ltd | Belfast Northern Ireland, United Kingdom | Complaint file establishment, Manufacturer | 1 | July 28, 2009 | 0 | 0 | 0 | api.fda.gov |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 1 | April 24, 2000 | 0 | 0 | 0 | api.fda.gov |
| Leo Medical Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 1 | June 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Millennium Surgical Corp | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 1 | April 24, 2000 | 0 | 0 | 0 | api.fda.gov |
| Sapi Med S.P.A | Alessandria, Italy | Manufacturer | 1 | September 26, 2007 | 0 | 0 | 0 | api.fda.gov |
| THD SPA | Correggio Reggio Emilia, Italy | Manufacturer | 1 | July 15, 2010 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices Pvt. Ltd. | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biorad Medisys Pvt. Ltd. | Pune Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Health Microport Medical Device Co.,ltd. | Changzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Ireland Ltd | LIMERICK Limerick(County), Ireland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CRH Medical Corporation | VANCOUVER British Columbia, Canada | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crown Surgical Corp. | Sialkot Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fetzer Medical GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fetzer Surgical, LLC | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Finemedix | Daegu Gwangyeogsi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G-Flex Europe SRL | Nivelles Brabant Wallon, Belgium | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulmag International | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hazel Enterprises | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inka Surgical Instruments | Jandakot Western Australia, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insightra Medical, Inc. | Clarksville, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Grit Medical Technology Co., Ltd. | changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Shenli Medical Production Co.,ltd | CHANGZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LHC Power Bander LLC | Milford, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Madina Surgical Works | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mclean Medical & Scientific | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mian Shahid Corp. | MUZAFFAR PUR, SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pathway Medtech, LLC. | Santee, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scanlan International, Inc. | Saint Paul, MN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sobytek Instruments Co. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southmedic, Inc. | BARRIE Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacebander Corporation | Hillsborough, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surtex Instruments Ltd | London Surrey, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Surgical GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Washington Surgical International | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Care (wuhan) Medical Technology Co., Ltd. | Wuhan Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wilbur Hill LLC | Rockville, MD, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weco Manufacturing Group-Henrietta | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuji Pengtian Medical Instrument Co.,Ltd. | Zhuji Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 6, 2022. 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.