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Data / Medical devices / Staple, Implantable / United States

FDA-registered makers of Staple, Implantable in the United States: 49 establishments

49 establishments in the United States are registered with the FDA to make Staple, Implantable (product code GDW). 21 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device
Staple, Implantable
Product code
GDW
Country
United States

Makers of Staple, Implantable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer46April 10, 20260230api.fda.gov
Ethicon Endo-Surgery, LLCGuaynabo, PR, United StatesManufacturer for export, Specification developer26May 11, 2026000api.fda.gov
Ethicon Endo-Surgery, Inc.Cincinnati, OH, United StatesSpecification developer23May 11, 20260194api.fda.gov
CovidienPonce, PR, United StatesContract manufacturer, Manufacturer21April 10, 2026000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer8February 20, 2018000api.fda.gov
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI, United StatesComplaint file establishment, Specification developer5July 16, 2019020api.fda.gov
Lexington Medical, Inc.Bedford, MA, United StatesComplaint file establishment, Manufacturer5April 21, 2023000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesSpecification developer2June 3, 2004000api.fda.gov
Ethicon, Inc.Somerville, NJ, United StatesManufacturer2February 5, 2013010api.fda.gov
Ethicon, Inc.Raritan, NJ, United StatesSpecification developer2February 5, 2013000api.fda.gov
Ethicon, LLCGuaynabo, PR, United StatesManufacturer2February 5, 2013000api.fda.gov
Anika Therapeutics, Inc.Bedford, MA, United StatesSpecification developer1May 8, 2023000api.fda.gov
Bolder Surgical, LLCLouisville, CO, United StatesSpecification developer1February 11, 2014020api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1March 16, 2012000api.fda.gov
Opus KSD, Inc.East Pembroke, MA, United StatesManufacturer1April 9, 2014000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer1July 12, 2013010api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer1July 12, 2013000api.fda.gov
Surgin Surgical Instrumentation, Inc.Scottsdale, AZ, United StatesSpecification developer1February 23, 1989000api.fda.gov
Tools For Surgery, LLCStony Brook, NY, United StatesManufacturer1March 25, 2004000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer1April 28, 2021000api.fda.gov
Teleflex Medical Inc.Cincinnati, OH, United StatesSpecification developer1April 28, 2021000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
AtalysAsheboro, NC, United StatesContract manufacturer0000api.fda.gov
Bard Shannon LimitedHumacao, PR, United StatesContract manufacturer0000api.fda.gov
Carbon Medical Technologies, Inc.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Engineered Plastic Components, Inc.Osceola, WI, United StatesContract manufacturer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer for export, Specification developer0010api.fda.gov
Intuitive Surgical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Manufacturer for export0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Isomedix Operations Inc.Grand Prairie, TX, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations Inc.San Diego, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Lacey Manufacturing Company LLCBridgeport, CT, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
Mass Precision, Inc.Fremont, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Nypro Healthcare Baja Inc. (Albuquerque)Albuquerque, NM, United StatesContract manufacturer, Contract sterilizer, Manufacturer for export0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Samax Precision Inc.Sunnyvale, CA, United StatesContract manufacturer0000api.fda.gov
Sharp Fluidics, Inc.El Granada, CA, United StatesSpecification developer0000api.fda.gov
Supreme Screw ProductsPlainview, NY, United StatesContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Tessy Plastics Corp.Skaneateles, NY, United StatesContract manufacturer0000api.fda.gov
Usgi MedicalSan Clemente, CA, United StatesManufacturer0000api.fda.gov
Veridiam, LLCEl Cajon, CA, United StatesContract manufacturer0000api.fda.gov
Viant Medical, IncS Plainfield, NJ, United StatesContract manufacturer0000api.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.