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Data / Medical devices / Arthroscope / United States

FDA-registered makers of Arthroscope in the United States: 126 establishments

126 establishments in the United States are registered with the FDA to make Arthroscope (product code HRX). 58 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
Arthroscope
Product code
HRX
Country
United States

Makers of Arthroscope in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler35August 26, 2026000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesManufacturer, Specification developer30July 20, 2020030api.fda.gov
Linvatec CorporationLargo, FL, United StatesComplaint file establishment, Manufacturer, Specification developer21November 14, 2018050api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer19May 20, 1998010api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer, Repackager or relabeler18July 20, 2020000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer15February 26, 2024020api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer12December 1, 2020070api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer10May 16, 2025000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer8July 23, 2015010api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer7May 6, 2024000api.fda.gov
Stryker Sustainability Solutions LakelandLakeland, FL, United StatesReprocessor6November 9, 2001010api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer5January 14, 2008020api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer5January 24, 2011000api.fda.gov
Hydrocision, Inc.Billerica, MA, United StatesRepackager or relabeler, Specification developer4April 16, 2020010api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer4June 6, 2006000api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4February 2, 2023020api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer, Manufacturer, Repackager or relabeler4December 21, 2018000api.fda.gov
Trice MedicalMalvern, PA, United StatesComplaint file establishment, Manufacturer, Specification developer4September 15, 2021000api.fda.gov
Clarus Medical, LLC.Minneapolis, MN, United StatesManufacturer3April 25, 2024000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler3July 31, 1997000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer3November 10, 1999000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler3November 24, 2000010api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer2October 10, 1996000api.fda.gov
Douglas Medical Products, IncMundelein, IL, United StatesComplaint file establishment, Specification developer2September 30, 1994000api.fda.gov
Elliquence LLCBaldwin, NY, United StatesManufacturer2June 11, 2018000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer2April 5, 2019000api.fda.gov
Hand Biomechanics Lab, Inc.Sacramento, CA, United StatesManufacturer2October 15, 2025000api.fda.gov
Integrated Endoscopy, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer2July 11, 2019000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer2November 24, 2000000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor2December 20, 2011010api.fda.gov
Orthopedic Sciences, IncOverland Park, KS, United StatesComplaint file establishment, Specification developer2February 26, 2014000api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer2October 14, 2026000api.fda.gov
Viseon, Inc.Irvine, CA, United StatesManufacturer2July 11, 2019000api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer1June 28, 2001010api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer1November 14, 2018000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer1October 18, 2022000api.fda.gov
E Surgical, LLCSparks, NV, United StatesSpecification developer1February 6, 2024000api.fda.gov
Insightra Medical, Inc.Clarksville, TN, United StatesComplaint file establishment, Specification developer1February 24, 2010000api.fda.gov
Intravu, Inc.Redwood City, CA, United StatesManufacturer1August 21, 2018000api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesManufacturer1August 12, 2020000api.fda.gov
Medtec Applications, Inc.Glendale Heights, IL, United StatesManufacturer1July 25, 1989000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer1October 9, 2019000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler1December 2, 1999000api.fda.gov
Nexus CMFSalt Lake City, UT, United StatesComplaint file establishment, Specification developer1March 18, 2008000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer1September 25, 1997000api.fda.gov
Pristine Surgical LLCPalm Harbor, FL, United StatesComplaint file establishment, Specification developer1December 21, 2022000api.fda.gov
Providence Medical Technology, Inc.Pleasanton, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1March 8, 2019000api.fda.gov
Prosurg, IncSan Jose, CA, United StatesManufacturer1July 11, 2016000api.fda.gov
Rafael Medical Devices, LLCNewark, NJ, United StatesSpecification developer1December 11, 2024000api.fda.gov
Renovo, Inc.Bend, OR, United StatesReprocessor1October 4, 2017010api.fda.gov
Santa Barbara Imaging SystemsGoleta, CA, United StatesManufacturer, Repackager or relabeler, Specification developer1March 18, 2008000api.fda.gov
Schoelly Usa Inc.Northborough, MA, United StatesManufacturer1June 2, 2014000api.fda.gov
SONEX HEALTH, IncEagan, MN, United StatesComplaint file establishment, Specification developer1September 29, 2025000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer1February 27, 2009000api.fda.gov
Spinal Simplicity, LLCOverland Park, KS, United StatesComplaint file establishment, Specification developer1April 16, 2026000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer, Specification developer1August 27, 2025000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesReprocessor, Specification developer1November 7, 2001010api.fda.gov
Stryker Sustainability Solutions - ChandlerChandler, AZ, United StatesReprocessor1November 7, 2001000api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
A&m Biomedical Inc.Laguna Hills, CA, United StatesContract manufacturer0000api.fda.gov
AB Medical Technologies, Inc.Redding, CA, United StatesContract manufacturer0000api.fda.gov
Accumedix, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Axcesor LLCMenomonee Falls, WI, 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
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
C & J Industries, Inc.Meadville, PA, United StatesContract manufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Criterion Tool & Die Inc DBA Criterion Precision MachiningBrookpark, OH, United StatesContract manufacturer0000api.fda.gov
D & R Products Co., Inc.Hudson, MA, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Global Interconnect, Inc.Pocasset, MA, United StatesContract manufacturer0000api.fda.gov
Henke Sass Wolf Of America, Inc.Dudley, MA, United StatesContract manufacturer0000api.fda.gov
Intl. Medsurg Connection, Inc.Schaumburg, IL, United StatesSpecification developer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Medline Industries, LP - SPTWaukegan, IL, United StatesContract manufacturer0000api.fda.gov
Medtronic Powered Surgical SolutionsFort Worth, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Midwest Interventional SystemsMaple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nexus Medical, LLCLenexa, KS, United StatesContract manufacturer0000api.fda.gov
Novatech Scientific LLCBoca Raton, FL, United StatesManufacturer for export0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Orthoscan, Inc.Scottsdale, AZ, United StatesManufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Pro-Dex, Inc.Irvine, CA, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Penn United Technologies, Inc.Warminster, PA, United StatesManufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Pro-Dex IncTustin, CA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Relign CorporationSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0010api.fda.gov
Roechling Medical Lancaster, LLCDenver, PA, United StatesContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Amery, WI, United StatesContract manufacturer0000api.fda.gov
STRYKER Communications, Inc.Flower Mound, TX, United StatesManufacturer0000api.fda.gov
SanminaSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Thermedx, LLCSolon, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
TranS1Magnolia, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, United StatesContract manufacturer0000api.fda.gov
Viant San Antonio, Inc.San Antonio, TX, United StatesContract manufacturer0000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, 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.