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Data / Medical devices / Needle, Gastro-Urology

Needle, Gastro-Urology (FHR): 22 FDA-registered makers in 7 countries

22 establishments in 7 countries are registered with the FDA to make Needle, Gastro-Urology (product code FHR, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 25, 1981, 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
FHR
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States9
Germany6
Pakistan3
South Korea1
Mexico1
Switzerland1
China1

Makers of Needle, Gastro-Urology

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
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Custom Tube Manufacturing LLCYangju-si Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Ilg Medizintechnik GMBHDURCHHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed GmbH dba Avalign German Specialty InstrumentsTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesSpecification developer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Unimed S.A.ECUBLENS Vaud, SwitzerlandContract manufacturer0000api.fda.gov
Uramix, Inc.E Lansdowne, PA, United StatesSpecification developer0000api.fda.gov
Uroplasty, LLCMinnetonka, MN, United StatesSpecification developer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov

Updated August 25, 1981. 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.