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Data / Medical devices / Arthroscope

Arthroscope (HRX): 225 FDA-registered makers in 24 countries

225 establishments in 24 countries are registered with the FDA to make Arthroscope (product code HRX, Class 2, 21 CFR 888.1100). 97 of them have a 510(k) clearance or PMA approval on file and 19 have a recall event. The FDA has issued 685 510(k) clearances under this code, the latest on October 14, 2026, and lists 52 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
HRX
Device class
2
Regulation
888.1100
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States126
Germany29
China12
Switzerland8
Mexico8
South Korea6
Italy6
Costa Rica5
Malaysia4
Dominican Republic3
France2
Taiwan2
United Kingdom2
Thailand2
Czechia1
Hong Kong1
Malta1
Nicaragua1
Honduras1
Canada1
Poland1
Hungary1
Ireland1
Bulgaria1

Makers of Arthroscope

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

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
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer23August 26, 2026000api.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
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer12October 18, 2022000api.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
Arthrocare CorporationCoyol Alajuela, Costa RicaManufacturer9June 28, 2001000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer9June 27, 2008010api.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
Arthrex GmbHMunich Bavaria, GermanyExporter to the US, Specification developer6August 3, 2009000api.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
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer5July 23, 2015000api.fda.gov
Stryker Tijuana OperationsTijuana Baja California, MexicoReprocessor5November 8, 2001000api.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
Novanta Medical S.R.O.Prelouc Pardubicky Kraj, CzechiaManufacturer3December 5, 2025000api.fda.gov
Novanta Medical GmbHLUDWIGSSTADT Bavaria, GermanyManufacturer3December 5, 2025010api.fda.gov
Novanta Medical GmbHBerlin, GermanySpecification developer3December 5, 2025000api.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
Eberle GmbH & Co. KGWURMBERG Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer2September 29, 2010000api.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
Hemodia SASLabege Haute-Garonne, FranceManufacturer2March 9, 2023000api.fda.gov
Hoogland Spine Products GmbHUnterfoehring Munich Bavaria, GermanyExporter to the US, Specification developer2October 9, 2009000api.fda.gov
Imedicom Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer2April 6, 2019000api.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
Olympus Winter & Ibe GMBHHamburg, GermanyManufacturer2April 21, 2016000api.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
asap endoscopic products GmbHUmkirch Baden-Wurttemberg, GermanyManufacturer2January 8, 2013000api.fda.gov
Adria SRL.San Giovanni in Persiceto Bologna, ItalyManufacturer1December 8, 2014010api.fda.gov
Aju Medical Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer1March 16, 2017000api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer1June 28, 2001010api.fda.gov
Biopsybell S.R.L.MIRANDOLA Modena, ItalyManufacturer, Repackager or relabeler1March 26, 2018000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer1November 14, 2018000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer, Manufacturer1November 21, 1994000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer1October 18, 2022000api.fda.gov
Dewimed Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1May 31, 2006000api.fda.gov
E Surgical, LLCSparks, NV, United StatesSpecification developer1February 6, 2024000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer1January 17, 1997000api.fda.gov
Innoview GMBHEichstetten Baden-Wurttemberg, GermanyManufacturer1September 11, 1996000api.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
Jiangsu Changmei Medtech Co.,ltdChangzhou Jiangsu, ChinaComplaint file establishment, Manufacturer1August 16, 2023000api.fda.gov
Joimax GMBHKARLSRUHE Baden-Wurttemberg, GermanyManufacturer1August 12, 2005000api.fda.gov
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer1October 1, 2020000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer1October 1, 2020000api.fda.gov
Medimaging Integrated Solution Inc.Hsinchu Hsinchu(City), TaiwanManufacturer1December 23, 2025000api.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
Modern Medical Equipment Manufacturing, Ltd.Kwai Chung, N.T., Hong KongContract manufacturer, Manufacturer1May 31, 2018000api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer1November 24, 2000000api.fda.gov
Medtronic Medical Costa Rica S.R.L.Coyol Alajuela, Costa RicaManufacturer1November 10, 1999000api.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
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1April 14, 2014000api.fda.gov
Santa Barbara Imaging SystemsGoleta, CA, United StatesManufacturer, Repackager or relabeler, Specification developer1March 18, 2008000api.fda.gov
Schoelly Fiberoptic, GMBHDENZLINGEN Baden-Wurttemberg, GermanyManufacturer1June 2, 2014000api.fda.gov
Schoelly Usa Inc.Northborough, MA, United StatesManufacturer1June 2, 2014000api.fda.gov
Shanghai Lange Medtech Co., Ltd.Shanghai, ChinaManufacturer1November 3, 2025000api.fda.gov
SONEX HEALTH, IncEagan, MN, United StatesComplaint file establishment, Specification developer1September 29, 2025000api.fda.gov
SoproLA CIOTAT CEDEX Bouches-du-Rhone, FranceManufacturer1July 11, 2008000api.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 Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer1February 24, 1988000api.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
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1December 7, 2012000api.fda.gov
Taeyeon Medical Co., Ltd.Wonju-si Gangwon, South KoreaManufacturer1February 3, 2021000api.fda.gov
Tecres SPAVERONA Veneto, ItalyExporter to the US, Manufacturer1August 16, 2023000api.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
Baxter Productos Medicos, Ltda.1-7052 Cartago, Costa RicaManufacturer0000api.fda.gov
BM Korea Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Bruetsch Technology AGBeringen Schaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Baxter Healthcare, S.A.Haina San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Baxter LimitedMarsa, MaltaSpecification developer0000api.fda.gov
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
C & J Industries, Inc.Meadville, PA, United StatesContract manufacturer0000api.fda.gov
CEA Global Dominicana d.b.a. Nissha Medical TechnologiesSan Pedro de Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
Command Medical Nicaragua SAManagua, NicaraguaContract manufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract 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
Dongguan Bao Kang Dian Zi Ke Ji LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Dragon Crown Medical Co., Ltd.Jinan Shandong, ChinaManufacturer0000api.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
G21 S.R.I.San Possidonio Modena, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Gebruder Renggli, AGSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Global Interconnect, Inc.Pocasset, MA, United StatesContract manufacturer0000api.fda.gov
GS Medical Co., Ltd.Heungdeok-gu, Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Gyrus Medical Ltd.CARDIFF Wales, United KingdomContract manufacturer0000api.fda.gov
Hanchang Co., LtdBucheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Henke Sass Wolf Of America, Inc.Dudley, MA, United StatesContract manufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Infus Medical (thailand) Co., Ltd.Amphoe Muang Samutprakarn Samut Prakan, ThailandContract manufacturer0000api.fda.gov
Infus Medical Co., Ltd.Khon Kaen Province, ThailandContract manufacturer0000api.fda.gov
Intl. Medsurg Connection, Inc.Schaumburg, IL, United StatesSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
J. Sterling Industries Ltd.Concord Ontario, CanadaContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jiangsu Shenli Medical Production Co.,ltdCHANGZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Joline GMBH & Co. KGHECHINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Jr-Medizintechnik GMBH & Co KGLeibertingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Koscher & Wuertz GMBHSPAICHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
L Z Form KFTAjka Veszprem(County), HungaryContract 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
Merit Medical Ireland, LtdGalway Galway(County), IrelandContract manufacturer0000api.fda.gov
Mi3 LimitedBlackburn Lancashire, United KingdomContract manufacturer0000api.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
Modern Medical Equipment Manufacturing (qing Yuan) LtdQING YUAN Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Modern Medical Equipment Manufacturing Ltd.HENG LI, DONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
New Deantronics Taiwan Ltd.New Taipei City, TaiwanContract 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
Nitinol Devices & Components Costa Rica, S. R. L.El Coyol Alajuela, Costa RicaContract 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
Pan-International Precision Electronic Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Peter's Technology (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaContract 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
RAUMEDIC - MuenchbergHelmbrechts Bavaria, GermanyContract 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
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Roechling Medical Lancaster, LLCDenver, PA, United StatesContract manufacturer0000api.fda.gov
Schmid Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Schoelly-Optix OodPanagyurishte Pazardzhik, BulgariaContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Amery, WI, United StatesContract manufacturer0000api.fda.gov
Scivita Medical Technology Co., Ltd.suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
SHANGHAI KiNETIC MEDICAL CO LTDShanghai, ChinaManufacturer0000api.fda.gov
STERIL VERONA s.r.l.ERBE Verona, ItalyContract manufacturer, Contract sterilizer0000api.fda.gov
Steripack Asia Sdn BhdKlang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
STRYKER Communications, Inc.Flower Mound, TX, United StatesManufacturer0000api.fda.gov
Sutter Medizintechnik GMBHEmmendingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
SanminaSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Surgical Specialties Mexico S DE RL DE CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Telea Electronic Engineering S.R.L.Sandrigo Vicenza, ItalyManufacturer0000api.fda.gov
Thermedx, LLCSolon, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Teufel & Gerlach GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
TranS1Magnolia, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Vomed Volzer Medizintechnik GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Venusa de Mexico S. de R.L de C.VCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.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 October 14, 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.