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Data / Medical devices / Needle, Hypodermic, Single Lumen / United States

FDA-registered makers of Needle, Hypodermic, Single Lumen in the United States: 99 establishments

99 establishments in the United States are registered with the FDA to make Needle, Hypodermic, Single Lumen (product code FMI). 67 have a 510(k) clearance or PMA approval on file and 14 have a recall event. FDA data exported November 3, 2026.

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Device
Needle, Hypodermic, Single Lumen
Product code
FMI
Country
United States

Makers of Needle, Hypodermic, Single Lumen in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer18November 9, 2018020api.fda.gov
Carefusion 2200, Inc.Vernon Hills, IL, United StatesComplaint file establishment, Specification developer17May 27, 2016000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesComplaint file establishment, Specification developer16December 20, 20180160api.fda.gov
Embecta Medical II LLCParsippany, NJ, United StatesComplaint file establishment, Specification developer8December 28, 2022020api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer7October 25, 2001000api.fda.gov
Sol-Millennium Medical, Inc.Chicago, IL, United StatesComplaint file establishment, Specification developer7February 17, 2022000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer6August 26, 2021000api.fda.gov
Ulti Med, Inc.De Smet, SD, United StatesManufacturer, Repackager or relabeler, Specification developer6December 16, 2021000api.fda.gov
Becton Dickinson And CompanyColumbus, NE, United StatesManufacturer5July 19, 2002000api.fda.gov
Becton, DIckinson and CompanyCanaan, CT, United StatesManufacturer4June 3, 1998000api.fda.gov
Cardinal HealthDeland, FL, United StatesManufacturer4October 25, 2001000api.fda.gov
Exelint International, Co.Redondo Beach, CA, United StatesManufacturer, Specification developer4November 2, 2015010api.fda.gov
MHC Medical ProductsFairfield, OH, United StatesComplaint file establishment, Specification developer4March 12, 2019010api.fda.gov
Ocuject, LLCSan Diego, CA, United StatesManufacturer, Specification developer4November 27, 2023000api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.Sandy, UT, United StatesSpecification developer3June 3, 1998000api.fda.gov
CarefusionSan Diego, CA, United StatesSpecification developer3June 3, 1998000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer3May 29, 2014000api.fda.gov
Multi-Med, Inc.Keene, NH, United StatesContract manufacturer, Manufacturer3August 27, 1997020api.fda.gov
Altaviz, LLCIrvine, CA, United StatesComplaint file establishment, Specification developer2July 27, 2023000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesComplaint file establishment, Specification developer2July 25, 2023000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer2May 30, 1980000api.fda.gov
Bellus Medical, LLCJohnson City, TN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2November 5, 2020000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesManufacturer for export, Specification developer2November 13, 2019032api.fda.gov
Cardinal HealthNorfolk, NE, United StatesManufacturer2October 25, 2001000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer2July 26, 2016000api.fda.gov
ICU Medical, Inc.Southington, CT, United StatesManufacturer2August 26, 2021000api.fda.gov
Intl. Medsurg Connection, Inc.Schaumburg, IL, United StatesSpecification developer2August 18, 2011010api.fda.gov
Plasti-Products, Inc.Omaha, NE, United StatesContract manufacturer, Manufacturer2July 3, 1997000api.fda.gov
Post Medical, Inc.Alpharetta, GA, United StatesManufacturer, Repackager or relabeler, Specification developer2April 21, 1999000api.fda.gov
Retractable Technologies, Inc.Little Elm, TX, United StatesComplaint file establishment, Manufacturer2June 17, 2014010api.fda.gov
Spectrum VascularWarren, NJ, United StatesManufacturer, Specification developer2July 30, 2025000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler2September 26, 2007000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer1July 2, 1996000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer1April 23, 1998000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer1January 10, 1997000api.fda.gov
Atrion Medical Products, Inc.Arab, AL, United StatesManufacturer1May 25, 2005000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer1July 2, 1996000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesSpecification developer1February 28, 1994010api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler1April 17, 2006000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesSpecification developer1August 6, 2020000api.fda.gov
Care Living Diagnostics IncSouth Setauket, NY, United StatesComplaint file establishment, Specification developer1July 1, 2022000api.fda.gov
Chinook Medical Gear, Inc.Tulsa, OK, United StatesRepackager or relabeler, Specification developer1November 9, 2018000api.fda.gov
CHS USA IncorporatedPeachtree City, GA, United StatesSpecification developer1September 20, 2023000api.fda.gov
Duopross Meditech CorporationFarmingdale, NY, United StatesSpecification developer1December 5, 2005000api.fda.gov
Facet Technologies, LLC.Atlanta, GA, United StatesComplaint file establishment, Specification developer1May 13, 2014000api.fda.gov
Greiner Bio-One North America, Inc.Monroe, NC, United StatesManufacturer1December 29, 2003060api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesSpecification developer1May 18, 2000000api.fda.gov
Hospitec USAFort Smith, AR, United StatesSpecification developer1January 18, 1996000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer1November 27, 1991000api.fda.gov
MEDLINE INDUSTRIES - MundeleinMundelein, IL, United StatesManufacturer1July 5, 1995000api.fda.gov
MPS Pharma & Medical, Inc.Brea, CA, United StatesManufacturer1July 15, 1998000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer1August 23, 1994000api.fda.gov
Norfolk Medical Products, Inc.Skokie, IL, United StatesRepackager or relabeler, Specification developer1August 20, 2015000api.fda.gov
Nxstage Medical, Inc.Lawrence, MA, United StatesComplaint file establishment, Specification developer1June 6, 1991000api.fda.gov
Pegasus ImportsHouston, TX, United StatesSpecification developer1May 29, 2014000api.fda.gov
Primrose Medical, Inc.East Walpole, MA, United StatesManufacturer1October 17, 1988000api.fda.gov
Sam Medical ProductsTualatin, OR, United StatesContract manufacturer, Specification developer1November 21, 2019000api.fda.gov
Solutions, Inc.Jeffersonville, IN, United StatesSpecification developer1July 10, 1995000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesSpecification developer1January 30, 1989000api.fda.gov
Stat Medical Devices, Inc.North Miami Beach, FL, United StatesSpecification developer1October 2, 2009010api.fda.gov
Stericycle, Inc.Bannockburn, IL, United StatesComplaint file establishment, Specification developer1December 16, 1999000api.fda.gov
Sharps Compliance, Inc.Houston, TX, United StatesSpecification developer1December 14, 1994000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer1October 23, 1987000api.fda.gov
Vygon MFGDover, NH, United StatesContract manufacturer, Manufacturer1October 23, 1987020api.fda.gov
WCM Waste & Compliance Management, Inc.Carlsbad, CA, United StatesManufacturer1September 1, 2009000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer1November 20, 2013000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer, Manufacturer1July 2, 2024000api.fda.gov
Aivita Biomedical, Inc.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0010api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Cardinal Health 200, LLCJacksonville, TX, United StatesContract manufacturer0000api.fda.gov
Carefusion 2200, Inc.Mannford, OK, United StatesContract manufacturer0000api.fda.gov
CLAYENS Crystal Lake, LLCCrystal Lake, IL, United StatesContract manufacturer0000api.fda.gov
Commercial PlasticsKenosha, WI, United StatesContract manufacturer0000api.fda.gov
Donatelle Plastics, LLCNew Brighton, MN, United StatesContract manufacturer0000api.fda.gov
Ecomed Solutions, LLCLindenhurst, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Greystone Medical, LLCWaterford, MI, United StatesSpecification developer0000api.fda.gov
Heron Therapeutics, Inc.Cary, NC, United StatesSpecification developer0000api.fda.gov
Intl. Medical IndustriesPompano Beach, FL, United StatesManufacturer0000api.fda.gov
Isomedix Operations Inc.Northborough, MA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
IntriCon Corporation VHVadnais Heights, MN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Lineage Biomedical, IncStuart, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Onetouch Medical, LLCCypress, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
PicocylGolden, CO, United StatesContract manufacturer0000api.fda.gov
Plas-Tech Engineering, LLCLake Geneva, WI, United StatesManufacturer for export0000api.fda.gov
PicocylGolden, CO, United StatesContract manufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Staclear, Inc.Raleigh, NC, United StatesManufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Universal Plastics - LatrobeLatrobe, PA, United StatesContract manufacturer0000api.fda.gov
Vault Paragon Group, Inc.Garden City, ID, United StatesComplaint file establishment, Contract manufacturer, Specification developer0000api.fda.gov
Vita Needle Co.Needham, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Viant Upland, IncUpland, CA, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.