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Data / Medical devices / Guide, Needle, Surgical / United States

FDA-registered makers of Guide, Needle, Surgical in the United States: 51 establishments

51 establishments in the United States are registered with the FDA to make Guide, Needle, Surgical (product code GDF). 1 has a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

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Device
Guide, Needle, Surgical
Product code
GDF
Country
United States

Makers of Guide, Needle, Surgical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer1March 11, 1985000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0010api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Avnet, Inc. (Avnet Logistics)Chandler, AZ, United StatesContract manufacturer0000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesComplaint file establishment, Specification developer0020api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Cinova Medical Inc.Phoenix, AZ, United StatesContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Elliquence LLCBaldwin, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesSpecification developer0010api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Katalyst Surgical, LLCChesterfield, MO, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Specification developer0000api.fda.gov
Kerylos CorporationReno, NV, United StatesSpecification developer0000api.fda.gov
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0010api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Needle Specialty ProductsBoyle, MS, United StatesContract manufacturer0000api.fda.gov
Orthopedic Sciences, IncOverland Park, KS, United StatesSpecification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Philips DS North America LLCGainesville, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Ridge & Crest CompanyMonterey Park, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesSpecification developer0000api.fda.gov
Steripack Usa (limited) LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Sureax Medical, CorporationSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.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
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification 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.