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Data / Medical devices / Holder, Needle, Gastroenterologic / United States

FDA-registered makers of Holder, Needle, Gastroenterologic in the United States: 46 establishments

46 establishments in the United States are registered with the FDA to make Holder, Needle, Gastroenterologic (product code FHQ). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Holder, Needle, Gastroenterologic
Product code
FHQ
Country
United States

Makers of Holder, Needle, Gastroenterologic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Accurate Surgical & Scientific Instruments Corp.Westbury, NY, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aurora Surgical, LLCSt Petersburg, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Black & Black Surgical, Inc.Tucker, GA, United StatesSpecification developer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Delasco, LLCPlano, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
H & H Co.Hayden, ID, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Holmed LLCAttleboro, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Hu-Friedy MFG Co., LLCDes Plaines, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Innomed, Inc.Savannah, GA, United StatesSpecification developer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Infinity Medical International LLCMiami, FL, United StatesManufacturer for export0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Kapstone ManufacturingCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
Katena Products, Inc.Fenton, MO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
M & C Specialties Co.Southampton, PA, United StatesContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Molded Products Inc.Harlan, IA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer, Specification developer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Suture Shield, IncRavenna, NE, United StatesSpecification developer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Total Titanium, Inc.Red Bud, IL, United StatesContract manufacturer, Manufacturer0000api.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
Vitalcor, Inc.Westmont, IL, United StatesSpecification developer0000api.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.