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Data / Medical devices / Needle, Suturing, Disposable / United States

FDA-registered makers of Needle, Suturing, Disposable in the United States: 31 establishments

31 establishments in the United States are registered with the FDA to make Needle, Suturing, Disposable (product code GAB). 0 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Needle, Suturing, Disposable
Product code
GAB
Country
United States

Makers of Needle, Suturing, Disposable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Anchor Products Co.Addison, IL, United StatesManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0010api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Cayenne Medical, Inc.Scottsdale, AZ, United StatesManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Design Concepts And Enterprises, LLCCentral Square, NY, United StatesContract manufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Key Surgical, LLCEden Prairie, MN, United StatesSpecification developer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesManufacturer0000api.fda.gov
Lincotek Medical LLCBartlett, TN, United StatesSpecification developer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0010api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Needle Specialty ProductsBoyle, MS, United StatesContract manufacturer0000api.fda.gov
New Wave EndoCoconut Creek, FL, United StatesManufacturer0000api.fda.gov
NewGen SurgicalSan Rafael, CA, United StatesSpecification developer0000api.fda.gov
R-Med, Inc.Oregon, OH, United StatesManufacturer, Specification developer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Winter Innovations, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, 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.