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Data / Medical devices / Needle, Aspiration And Injection, Reusable / United States

FDA-registered makers of Needle, Aspiration And Injection, Reusable in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Needle, Aspiration And Injection, Reusable (product code GDM). 1 has 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
Needle, Aspiration And Injection, Reusable
Product code
GDM
Country
United States

Makers of Needle, Aspiration And Injection, Reusable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer1March 9, 1987000api.fda.gov
Anodyne SurgicalO Fallon, MO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
H & H Co.Hayden, ID, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Hart Enterprises, Inc.Sparta, MI, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
PDV MedTechMorgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Regenmed Systems Inc.Half Moon Bay, CA, United StatesSpecification developer0000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler, Specification 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 developer0010api.fda.gov
Tulip Medical Products, Inc.San Diego, CA, United StatesManufacturer0000api.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.