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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.

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Product code
FHN
Device class
2
Regulation
876.4400
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States20
China12
Pakistan8
Germany5
United Kingdom2
Italy2
India2
Canada2
Mexico2
Austria1
Costa Rica1
Ireland1
South Korea1
Belgium1
Australia1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
A.M.I. Agency For Medical Innovations GMBHFeldkirch Vorarlberg, AustriaManufacturer1June 12, 2015000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaManufacturer1June 6, 2022000api.fda.gov
Haemoband Surgical LtdBelfast Northern Ireland, United KingdomComplaint file establishment, Manufacturer1July 28, 2009000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler1April 24, 2000000api.fda.gov
Leo Medical Co., Ltd.Changzhou Jiangsu, ChinaManufacturer1June 14, 2018000api.fda.gov
Millennium Surgical CorpSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler1April 24, 2000000api.fda.gov
Sapi Med S.P.AAlessandria, ItalyManufacturer1September 26, 2007000api.fda.gov
THD SPACorreggio Reggio Emilia, ItalyManufacturer1July 15, 2010000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Alton Shanghai Medical Instruments Co LtdShanghai, ChinaManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Biorad Medisys Pvt. Ltd.Pune Maharashtra, IndiaManufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Changzhou Health Microport Medical Device Co.,ltd.Changzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Cook Ireland LtdLIMERICK Limerick(County), IrelandComplaint file establishment, Manufacturer0000api.fda.gov
CRH Medical CorporationVANCOUVER British Columbia, CanadaComplaint file establishment, Specification developer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
FinemedixDaegu Gwangyeogsi, South KoreaManufacturer0000api.fda.gov
G-Flex Europe SRLNivelles Brabant Wallon, BelgiumSpecification developer0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hazel EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Insightra Medical, Inc.Clarksville, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Grit Medical Technology Co., Ltd.changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Shenli Medical Production Co.,ltdCHANGZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
LHC Power Bander LLCMilford, OH, United StatesSpecification developer0000api.fda.gov
Madina Surgical WorksSialkot Punjab, PakistanManufacturer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer0000api.fda.gov
Pathway Medtech, LLC.Santee, CA, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Sobytek Instruments Co.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Southmedic, Inc.BARRIE Ontario, CanadaContract manufacturer0000api.fda.gov
Spacebander CorporationHillsborough, NJ, United StatesManufacturer0000api.fda.gov
Surtex Instruments LtdLondon Surrey, United KingdomManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesManufacturer0000api.fda.gov
Washington Surgical InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Well Care (wuhan) Medical Technology Co., Ltd.Wuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wilbur Hill LLCRockville, MD, United StatesSpecification developer0000api.fda.gov
Weco Manufacturing Group-HenriettaRochester, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Zhuji Pengtian Medical Instrument Co.,Ltd.Zhuji Zhejiang, ChinaManufacturer0000api.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.