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Data / Medical devices / Syringe, Piston / United States

FDA-registered makers of Syringe, Piston in the United States: 145 establishments

145 establishments in the United States are registered with the FDA to make Syringe, Piston (product code FMF). 86 have a 510(k) clearance or PMA approval on file and 16 have a recall event. FDA data exported November 2, 2026.

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Device
Syringe, Piston
Product code
FMF
Country
United States

Makers of Syringe, Piston in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Becton DickinsonFranklin Lakes, NJ, United StatesComplaint file establishment, Specification developer11July 29, 20250200api.fda.gov
Sol-Millennium Medical, Inc.Chicago, IL, United StatesComplaint file establishment, Specification developer10August 25, 2026010api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer9August 22, 2025000api.fda.gov
Cardinal HealthNorfolk, NE, United StatesManufacturer8August 22, 2025000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer7November 4, 20250100api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer6May 2, 2005000api.fda.gov
Becton, DIckinson and CompanyCanaan, CT, United StatesManufacturer6December 19, 2016000api.fda.gov
Micromedics, Inc.Saint Paul, MN, United StatesManufacturer6November 30, 2017000api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer6August 26, 2026000api.fda.gov
Embecta Medical II LLCParsippany, NJ, United StatesComplaint file establishment, Specification developer5July 13, 2026000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer5December 9, 2022030api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer4July 7, 2015000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer4August 11, 2022000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer4May 2, 2008010api.fda.gov
MHC Medical ProductsFairfield, OH, United StatesComplaint file establishment, Specification developer4December 29, 2016000api.fda.gov
Ulti Med, Inc.De Smet, SD, United StatesManufacturer, Specification developer4November 29, 2006010api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Repackager or relabeler3June 10, 2011010api.fda.gov
Cardinal HealthDeland, FL, United StatesManufacturer3August 22, 2025000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesComplaint file establishment, Specification developer3June 24, 2025000api.fda.gov
Duopross Meditech CorporationFarmingdale, NY, United StatesSpecification developer3December 17, 2025000api.fda.gov
Instylla, Inc.Bedford, MA, United StatesManufacturer3December 22, 2025000api.fda.gov
Intl. Medsurg Connection, Inc.Schaumburg, IL, United StatesSpecification developer3August 18, 2011010api.fda.gov
Integra LifeSciences CorporationPrinceton, NJ, United StatesComplaint file establishment, Specification developer3June 5, 2009032api.fda.gov
Procedure Products, Inc.Vancouver, WA, United StatesManufacturer3March 27, 2017000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler3August 29, 2000000api.fda.gov
Vascular Integrity, LLCHuntington Beach, CA, United StatesSpecification developer3March 4, 1997000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer3November 20, 2013000api.fda.gov
embecta medical I LLCHoldrege, NE, United StatesContract manufacturer, Manufacturer3July 13, 2026000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler2June 26, 1990000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesSpecification developer2August 29, 2000011api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer2August 29, 2000020api.fda.gov
Arteriocyte Medical Systems, Inc.Hopkinton, MA, United StatesManufacturer, Repackager or relabeler, Specification developer2September 29, 2004000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer2May 16, 2012000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer2September 20, 2012010api.fda.gov
Avitus Orthopaedics, IncShelton, CT, United StatesSpecification developer2July 17, 2023000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer2March 8, 1982000api.fda.gov
Becton Dickinson And CompanyColumbus, NE, United StatesManufacturer2May 13, 2011000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer, Specification developer2August 27, 2014020api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Specification developer2December 17, 2014000api.fda.gov
CarefusionSan Diego, CA, United StatesSpecification developer2September 25, 2023000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer2June 24, 2025000api.fda.gov
Exelint International, Co.Redondo Beach, CA, United StatesManufacturer, Specification developer2December 12, 2025000api.fda.gov
Eli Lilly and Company, Pharmaceutical Delivery SystemsIndianapolis, IN, United StatesManufacturer, Specification developer2June 3, 2016000api.fda.gov
Medela LLCMchenry, IL, United StatesManufacturer2October 27, 2009020api.fda.gov
Milestone Scientific, Inc.Roseland, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer2June 9, 2017000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesComplaint file establishment, Specification developer2November 30, 2023000api.fda.gov
Retractable Technologies, Inc.Little Elm, TX, United StatesComplaint file establishment, Manufacturer2February 24, 2011000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer2July 8, 2016000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer1September 28, 1988000api.fda.gov
Baxter Healthcare CorporationCleveland, MS, United StatesManufacturer1June 24, 2002000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Repackager or relabeler1May 10, 2018000api.fda.gov
Bioventus LLCDurham, NC, United StatesComplaint file establishment, Manufacturer, Specification developer1June 25, 2024000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesSpecification developer1September 30, 1992000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesSpecification developer1January 6, 2020000api.fda.gov
CHS USA IncorporatedPeachtree City, GA, United StatesSpecification developer1November 30, 2023000api.fda.gov
Control Medical TechnologySouth Salt Lake, UT, United StatesSpecification developer1October 4, 2007000api.fda.gov
Daxor CorporationOak Ridge, TN, United StatesSpecification developer1December 22, 1997000api.fda.gov
Ecomed Solutions, LLCLindenhurst, IL, United StatesComplaint file establishment, Specification developer1March 23, 2023000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer1August 11, 2022000api.fda.gov
Global Life Sciences Solutions USA LLCMarlborough, MA, United StatesComplaint file establishment, Specification developer1September 6, 1994000api.fda.gov
Intl. Medical IndustriesPompano Beach, FL, United StatesManufacturer1September 4, 2024000api.fda.gov
JB Medical Development, LLC Dba/Md3, LLCSunrise, FL, United StatesSpecification developer1September 7, 2021000api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer1July 7, 2015000api.fda.gov
Lifenet HealthVirginia Beach, VA, United StatesManufacturer1July 13, 2020000api.fda.gov
Lineage Biomedical, IncStuart, FL, United StatesComplaint file establishment, Specification developer1November 30, 2023010api.fda.gov
LifeNet HealthPlainfield, IN, United StatesManufacturer1July 13, 2020000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer1April 23, 2015000api.fda.gov
Medone Surgical, Inc.Sarasota, FL, United StatesManufacturer1April 26, 2021000api.fda.gov
Medtronic MinimedNorthridge, CA, United StatesComplaint file establishment, Manufacturer1July 26, 2016010api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer1July 8, 1999000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer, Manufacturer for export1July 8, 1999000api.fda.gov
MPS Pharma & Medical, Inc.Brea, CA, United StatesManufacturer1September 12, 1989000api.fda.gov
Medline Industries (NAMIC Division) - Glen FallsGlens Falls, NY, United StatesManufacturer1April 14, 2014000api.fda.gov
Nessa Global Inc.Dover, DE, United StatesSpecification developer1September 7, 1990000api.fda.gov
Ocuject, LLCSan Diego, CA, United StatesSpecification developer1October 13, 2021000api.fda.gov
Onetouch Medical, LLCCypress, TX, United StatesRepackager or relabeler, Specification developer1September 12, 2019000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer1May 1, 2020000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer1September 16, 2016000api.fda.gov
Q.I. Medical, Inc.Grass Valley, CA, United StatesSpecification developer1September 6, 1994000api.fda.gov
Rhythmlink International, LLCColumbia, SC, United StatesManufacturer, Repackager or relabeler, Specification developer1April 12, 2011000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesSpecification developer1November 28, 2008000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer1May 18, 2005000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1May 18, 2005000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer1July 25, 2005000api.fda.gov
Us Infusion LLC. D/B/A Truecare Biomedix-UsaSouth Miami, FL, United StatesComplaint file establishment, Specification developer1September 15, 2021000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer1October 4, 2007000api.fda.gov
Aivita Biomedical, Inc.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
Apollo Renal Therapeutics, LLCOcala, FL, United StatesContract manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Brevet Inc.Huntington Beach, CA, United StatesContract manufacturer0000api.fda.gov
Baxter Healthcare of Puerto Rico LLCAibonito, PR, United StatesManufacturer0000api.fda.gov
Boehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, CT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
Care Living Diagnostics IncSouth Setauket, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Charter Medical, LLCWinston Salem, NC, United StatesManufacturer0000api.fda.gov
CLAYENS Crystal Lake, LLCCrystal Lake, IL, United StatesContract manufacturer0000api.fda.gov
Congruence Medical Solutions, LLCBaltimore, MD, United StatesSpecification developer0000api.fda.gov
Citra Labs LLCBraintree, MA, United StatesContract manufacturer0000api.fda.gov
CovidienNorth Haven, CT, United StatesContract manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
ETEX CorporationBraintree, MA, United StatesSpecification developer0000api.fda.gov
EmCyte CorporationFort Myers, FL, United StatesManufacturer0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Greystone Medical, LLCWaterford, MI, United StatesSpecification developer0000api.fda.gov
Gilero, IncPittsboro, NC, United StatesContract manufacturer0000api.fda.gov
Heron Therapeutics, Inc.Cary, NC, United StatesSpecification developer0000api.fda.gov
ICU Medical, Inc.Southington, CT, United StatesManufacturer0000api.fda.gov
Isomedix Operations Inc.Whippany, NJ, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations Inc.Chester, NY, United StatesManufacturer for export0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
Medical Components IncHarleysville, PA, United StatesManufacturer for export0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Testing - CT, LLCWillington, CT, United StatesContract manufacturer0000api.fda.gov
Packaging Coordinators, LLCPhila, PA, United StatesContract manufacturer0000api.fda.gov
Pall Life Sciences Puerto Rico, LLCFajardo, PR, United StatesContract manufacturer0000api.fda.gov
Pathway Medtech, LLC.Santee, CA, United StatesContract manufacturer0000api.fda.gov
Pegasus ImportsHouston, TX, United StatesSpecification developer0000api.fda.gov
Phoenix Medical Products, Inc.Mountain City, TN, United StatesContract manufacturer0000api.fda.gov
Plas-Tech Engineering, LLCLake Geneva, WI, United StatesManufacturer for export0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Prospect Life SciencesWestminster, CO, United StatesContract manufacturer0000api.fda.gov
Pharma Packaging Solutions, LLC dba Tjoapack, LLCClinton, TN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Regenlab USA LLCJersey City, NJ, United StatesManufacturer0000api.fda.gov
Staclear, Inc.Raleigh, NC, United StatesManufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Sharp Packaging Services, LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Tech Group Grand Rapids, Inc.Gr, MI, United StatesContract manufacturer0000api.fda.gov
The Metrix CompanyDubuque, IA, United StatesContract manufacturer0000api.fda.gov
Tricor SystemsElgin, IL, United StatesContract manufacturer0000api.fda.gov
True Diagnostics, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Thunderbird Molding GreensboroGreensboro, NC, United StatesContract manufacturer0000api.fda.gov
Tissue Transplant Technology, Ltd. d/b/a Bone Bank AllograftsSan Antonio, TX, United StatesContract manufacturer0000api.fda.gov
Vault Paragon Group, Inc.Garden City, ID, United StatesComplaint file establishment, Contract manufacturer, Specification developer0000api.fda.gov
Viant Medical, Inc.Grand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Viant San Antonio, Inc.San Antonio, TX, United StatesContract manufacturer0000api.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
West Pharmaceutical Services AZ, Inc.Tempe, AZ, United StatesContract manufacturer0000api.fda.gov
Zmi PharmaCarlsbad, CA, 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.