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Data / Medical devices / Kit, Surgical Instrument, Disposable / United States

FDA-registered makers of Kit, Surgical Instrument, Disposable in the United States: 83 establishments

83 establishments in the United States are registered with the FDA to make Kit, Surgical Instrument, Disposable (product code KDD). 4 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
Kit, Surgical Instrument, Disposable
Product code
KDD
Country
United States

Makers of Kit, Surgical Instrument, Disposable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer1December 4, 1987020api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer1April 16, 2008000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1December 4, 1987000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer, Specification developer1July 9, 1982010api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer0000api.fda.gov
Acuderm, Inc.Fort Lauderdale, FL, United StatesManufacturer0000api.fda.gov
Allergan Sales, LLCIrvine, CA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Astute Choice PackagingHenrico, VA, United StatesSpecification developer0000api.fda.gov
Austin Medical, Inc.Waynesville, NC, United StatesManufacturer, Specification developer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0010api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0020api.fda.gov
Boxspine, LLCPlymouth, IN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer for export0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesManufacturer, Specification developer0020api.fda.gov
Cadence Device, Inc.Cranberry Township, PA, United StatesContract manufacturer0000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0010api.fda.gov
Cardinal Health 200, LLCEl Paso, TX, United StatesManufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cygnus Medical LLCBranford, CT, United StatesSpecification developer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0040api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Eca Medical InstrumentsNewbury Park, CA, United StatesContract manufacturer0000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer0000api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus FlowerHorsham, PA, United StatesSpecification developer0000api.fda.gov
Footprint Medical Inc.San Antonio, TX, United StatesManufacturer0000api.fda.gov
Freudenberg Medical, LLCCarpinteria, CA, United StatesContract manufacturer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Gramercy Extremity Orthopedics, LLC.Richardson, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Gilero, IncPittsboro, NC, United StatesContract manufacturer0000api.fda.gov
I-Tek Medical, Inc.White Bear Lake, MN, United StatesContract sterilizer, Manufacturer0000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
MDM Wound Ventures, IncSan Antonio, TX, United StatesSpecification developer0000api.fda.gov
Medical Action Industries, Inc. 306Arden, NC, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0020api.fda.gov
MEDLINE INDUSTRIES, LP - LaredoLaredo, TX, United StatesManufacturer, Manufacturer for export, Repackager or relabeler0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer00222api.fda.gov
Medline Industries, LP - SPTWaukegan, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medone Surgical, Inc.Sarasota, FL, United StatesManufacturer0000api.fda.gov
Medshape, Inc.Atlanta, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Merit Medical Systems, IncChester, VA, United StatesContract manufacturer0010api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer0020api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Mindera CorporationVista, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Manus Medical, LLCHenrico, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Microspecialties LLCMiddletown, CT, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler0010api.fda.gov
NewGen SurgicalSan Rafael, CA, United StatesSpecification developer0000api.fda.gov
Oftal-One IncCoral Gables, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Paradyne Medical Products, IncBrea, CA, United StatesContract manufacturer0000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Proximate Concepts LLCAllendale, NJ, United StatesManufacturer0000api.fda.gov
Paragon Medical - SouthingtonSouthington, CT, United StatesContract manufacturer0000api.fda.gov
Qsum Biopsy Disposables LLCPequot Lakes, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ranfac Corp.Avon, MA, United StatesManufacturer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Spineology Inc.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer0020api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Sklar CorporationMalvern, PA, United StatesSpecification developer0000api.fda.gov
Sterling Medical ProductsProphetstown, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Trice MedicalMalvern, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Trinity Sterile, Inc.Salisbury, MD, United StatesManufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer0000api.fda.gov
Vortex Surgical, Inc.Saint Charles, MO, United StatesManufacturer, Specification developer0010api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer0000api.fda.gov
Windstone Medical Packaging, Inc.Billings, MT, United StatesComplaint file establishment, Contract manufacturer, Contract sterilizer, Repackager or relabeler0081api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Windstone Medical Packaging, Inc.Billings, MT, United StatesComplaint file establishment, Contract manufacturer, Contract sterilizer, Repackager or relabeler0000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, United StatesManufacturer0000api.fda.gov
voss medical productsSan Antonio, TX, 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.