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Data / Medical devices / Electrosurgical, Cutting & Coagulation & Accessories / United States

FDA-registered makers of Electrosurgical, Cutting & Coagulation & Accessories in the United States: 272 establishments

272 establishments in the United States are registered with the FDA to make Electrosurgical, Cutting & Coagulation & Accessories (product code GEI). 170 have a 510(k) clearance or PMA approval on file and 54 have a recall event. FDA data exported November 3, 2026.

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Device
Electrosurgical, Cutting & Coagulation & Accessories
Product code
GEI
Country
United States

Makers of Electrosurgical, Cutting & Coagulation & Accessories in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CovidienBoulder, CO, United StatesManufacturer, Manufacturer for export, Repackager or relabeler73September 15, 2026060api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer73September 15, 2026010api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler72August 26, 20220130api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Manufacturer, Specification developer56July 29, 2016000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer51March 2, 2026040api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer43April 27, 2023090api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer43April 21, 2016010api.fda.gov
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer35June 21, 2018020api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer32March 30, 2026080api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler27April 21, 2016000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer, Repackager or relabeler25December 11, 2023000api.fda.gov
Megadyne Medical Products, Inc.Cincinnati, OH, United StatesSpecification developer23July 12, 20240114api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer21September 17, 2026050api.fda.gov
Aesculap, Inc.Center Valley, PA, United StatesComplaint file establishment, Specification developer20December 18, 2020050api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer, Specification developer20March 24, 2020030api.fda.gov
Apyx Medical CorporationClearwater, FL, United StatesContract manufacturer, Manufacturer, Specification developer18June 9, 2023050api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler18April 21, 2016000api.fda.gov
Ethicon Endo-Surgery, LLCGuaynabo, PR, United StatesSpecification developer18January 17, 2025000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer17February 28, 2024000api.fda.gov
Ethicon Endo-Surgery, Inc.Cincinnati, OH, United StatesSpecification developer16January 17, 2025040api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer15October 31, 2025020api.fda.gov
Cynosure, LLCWestford, MA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer14November 23, 2022000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler14April 5, 2018010api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer14December 19, 2024020api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer, Repackager or relabeler14June 21, 2018000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer13October 14, 2022000api.fda.gov
Covidien llcSanta Clara, CA, United StatesSpecification developer13May 7, 2020030api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer12April 3, 2015030api.fda.gov
Kirwan Surgical Products, LLC.Marshfield, MA, United StatesManufacturer12October 20, 2005011api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer11August 26, 2022000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer11April 11, 2019000api.fda.gov
Linvatec CorporationLargo, FL, United StatesComplaint file establishment, Manufacturer, Specification developer11April 27, 2023010api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer, Specification developer11January 26, 20180110api.fda.gov
Elliquence LLCBaldwin, NY, United StatesManufacturer10May 3, 2017000api.fda.gov
Microline Surgical, IncBeverly, MA, United StatesComplaint file establishment, Manufacturer10April 23, 20240100api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer9August 5, 2024010api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer9October 12, 2018050api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesComplaint file establishment, Specification developer8August 19, 2025020api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer8June 26, 2009000api.fda.gov
Encision, Inc.Boulder, CO, United StatesManufacturer, Specification developer8July 15, 2020080api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer8May 25, 2005040api.fda.gov
Soniquence, LLCBaldwin, NY, United StatesManufacturer, Specification developer8January 27, 2026000api.fda.gov
Aerin Medical Inc.Mountain View, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer7May 18, 2026010api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer7February 23, 2018000api.fda.gov
Pulse Biosciences, Inc.Hayward, CA, United StatesComplaint file establishment, Manufacturer7August 5, 2024000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer7October 25, 2021000api.fda.gov
Stryker Sustainability Solutions LakelandLakeland, FL, United StatesRemanufacturer, Reprocessor7March 28, 2023010api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler7October 12, 2018000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer6April 17, 2014000api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer6January 17, 2018000api.fda.gov
Venus Concept Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer6November 6, 2025000api.fda.gov
Venus Concept Inc.Windham, NH, United StatesComplaint file establishment, Manufacturer, Specification developer6November 6, 2025000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesSpecification developer6March 23, 2023000api.fda.gov
CovidienPlainfield, IN, United StatesManufacturer5May 31, 2011000api.fda.gov
Delasco, LLCPlano, TX, United StatesManufacturer, Repackager or relabeler5May 23, 2000000api.fda.gov
Maquet Cardiovascular LLCWayne, NJ, United StatesManufacturer, Specification developer5May 30, 20250152api.fda.gov
Medrange CorporationBrea, CA, United StatesManufacturer, Specification developer5April 10, 2026000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer5February 3, 1998000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer5February 3, 1998000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesReprocessor, Specification developer5June 18, 2026000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Repackager or relabeler, Specification developer5May 21, 2020000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer4July 10, 2014000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer4April 17, 2014010api.fda.gov
C2Dx, Inc.Schoolcraft, MI, United StatesComplaint file establishment, Manufacturer4October 24, 2023000api.fda.gov
Canady Biotechnology LLCTakoma Park, MD, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer4November 21, 2019000api.fda.gov
CovidienPonce, PR, United StatesContract manufacturer, Manufacturer4October 5, 1999010api.fda.gov
Dynamic Diagnostics IncorporatedPlymouth, MI, United StatesRepackager or relabeler, Specification developer4July 16, 2015000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer, Repackager or relabeler4March 19, 1998000api.fda.gov
Ellusa, LLCBaldwin, NY, United StatesManufacturer, Specification developer4September 9, 2022000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer4November 15, 2023000api.fda.gov
Key Surgical, LLCEden Prairie, MN, United StatesSpecification developer4April 15, 2025000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer4February 26, 2010000api.fda.gov
Omni-Guide Holdings, Inc.Billerica, MA, United StatesComplaint file establishment, Manufacturer, Specification developer4January 2, 2015010api.fda.gov
Stryker Sustainability Solutions - ChandlerChandler, AZ, United StatesRemanufacturer, Reprocessor4June 18, 2026000api.fda.gov
Venclose, Inc.San Jose, CA, United StatesManufacturer4August 19, 2025000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, United StatesManufacturer, Repackager or relabeler4November 3, 2010010api.fda.gov
Angiodynamics, IncGlens Falls, NY, United StatesManufacturer3October 13, 2006060api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer3October 13, 2006020api.fda.gov
Bolder Surgical, LLCLouisville, CO, United StatesSpecification developer3September 7, 2021010api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer3April 17, 2014050api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer3March 6, 1996000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer3April 17, 2014000api.fda.gov
Lacey Manufacturing Company LLCBridgeport, CT, United StatesContract manufacturer, Manufacturer3October 25, 2013000api.fda.gov
LifeSync CorporationCoral Springs, FL, United StatesSpecification developer3September 19, 1997000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer3February 28, 2024000api.fda.gov
Nico CorporationIndianapolis, IN, United StatesComplaint file establishment, Specification developer3September 13, 2019010api.fda.gov
Relign CorporationSanta Clara, CA, United StatesSpecification developer3May 8, 2024000api.fda.gov
Rohrer Aesthetics, Inc.Homewood, AL, United StatesComplaint file establishment, Specification developer3May 22, 2024000api.fda.gov
Solta Medical, Inc.Bothell, WA, United StatesManufacturer, Remanufacturer3September 22, 2017040api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer, Specification developer3January 23, 2013000api.fda.gov
Atricure, Inc.Mason, OH, United StatesManufacturer, Repackager or relabeler, Specification developer2January 26, 2007000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Repackager or relabeler, Specification developer2July 31, 2014000api.fda.gov
Black & Black Surgical, Inc.Tucker, GA, United StatesRepackager or relabeler, Specification developer2January 18, 2008000api.fda.gov
Candela CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer2July 1, 2024000api.fda.gov
DannikOrlando, FL, United StatesComplaint file establishment, Specification developer2October 28, 2021000api.fda.gov
Flexbar Machine Corp.Islandia, NY, United StatesManufacturer, Repackager or relabeler2February 28, 2011000api.fda.gov
Gyrus Acmi, Inc.Bartlett, TN, United StatesManufacturer, Specification developer2April 5, 2013010api.fda.gov
I.C. Medical, Inc.Phoenix, AZ, United StatesManufacturer2April 5, 2016000api.fda.gov
Katalyst Surgical, LLCChesterfield, MO, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Specification developer2October 7, 2022000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesManufacturer, Repackager or relabeler2November 1, 2010010api.fda.gov
Microsurgical Technology, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer, Specification developer2May 18, 2006000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler2September 29, 2008000api.fda.gov
Nurse Assist, LLCHaltom City, TX, United StatesManufacturer2May 23, 1994000api.fda.gov
Plasma Surgical Inc.Roswell, GA, United StatesManufacturer2April 10, 2026010api.fda.gov
Preferred DepotIrvine, CA, United StatesRemanufacturer, Repackager or relabeler2August 16, 2013000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesManufacturer, Specification developer2January 30, 1995000api.fda.gov
Rebound Therapeutics, CorporationIrvine, CA, United StatesManufacturer2December 2, 2021000api.fda.gov
Stingray Surgical ProductsBoca Raton, FL, United StatesManufacturer, Repackager or relabeler2May 10, 2013010api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesSpecification developer2December 6, 2013000api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesSpecification developer2January 28, 2009000api.fda.gov
Terumo Cardiovascular Systems CorporationElkton, MD, United StatesManufacturer2April 21, 2016010api.fda.gov
The Reflux CompanySan Diego, CA, United StatesSpecification developer2September 23, 2015000api.fda.gov
Transamerican Technologies InternationalSan Ramon, CA, United StatesManufacturer, Repackager or relabeler2August 20, 1997000api.fda.gov
Aesthetics Biomedical Inc.Phoenix, AZ, United StatesComplaint file establishment, Manufacturer, Specification developer1October 16, 2022000api.fda.gov
Alto Development Corp.Farmingdale, NJ, United StatesContract manufacturer, Manufacturer1May 17, 1993000api.fda.gov
Applied Medical Technology, Inc.Brecksville, OH, United StatesManufacturer1July 21, 1997000api.fda.gov
Atc Technologies Inc.Wilmington, MA, United StatesContract manufacturer, Manufacturer1March 20, 2000000api.fda.gov
Atraverse MedicalSolana Beach, CA, United StatesComplaint file establishment, Specification developer1August 12, 2025000api.fda.gov
Atraverse MedicalCardiff by the Sea, CA, United StatesComplaint file establishment, Specification developer1August 12, 2025000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer1April 16, 2004000api.fda.gov
Aventix Medical IncLaguna Hills, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1March 27, 2026000api.fda.gov
Abbott MedicalPlano, TX, United StatesComplaint file establishment, Specification developer1January 28, 2009000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer1December 17, 2002000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer1January 30, 1995010api.fda.gov
Brera Medical IncorporatedNorthborough, MA, United StatesManufacturer1April 6, 2022000api.fda.gov
Britegums Inc.Cary, NC, United StatesSpecification developer1December 4, 2009000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesManufacturer, Specification developer1May 2, 1991030api.fda.gov
Broncus Medical IncSan Jose, CA, United StatesManufacturer1February 22, 2019000api.fda.gov
Cambridge Interventional LLCBurlington, MA, United StatesManufacturer1January 7, 2020000api.fda.gov
Cintron Medical CorporationWestminster, CO, United StatesContract manufacturer, Manufacturer1June 3, 2025000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1June 3, 2002020api.fda.gov
Cutera, Inc.Brisbane, CA, United StatesManufacturer1July 13, 2022000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1March 7, 1994000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer1March 7, 1994000api.fda.gov
E Surgical, LLCSparks, NV, United StatesSpecification developer1August 2, 2023000api.fda.gov
FHC, Inc.Bowdoin, ME, United StatesManufacturer1May 14, 2020000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer1July 28, 1981000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer1July 28, 1981000api.fda.gov
Innoblative Designs, Inc.Chicago, IL, United StatesComplaint file establishment, Specification developer1December 12, 2023000api.fda.gov
Ion Medical IncJacksonville, FL, United StatesManufacturer1December 13, 2007000api.fda.gov
Intuitive Surgical, Inc.Peachtree Corners, GA, United StatesManufacturer, Repackager or relabeler1January 7, 2014000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer1August 5, 2024000api.fda.gov
Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United StatesManufacturer, Specification developer1June 2, 1983000api.fda.gov
Liger MedicalLehi, UT, United StatesManufacturer1February 12, 2014000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer, Manufacturer1March 20, 2006000api.fda.gov
Macan Genesis Manufacturing LLCElmwood, WI, United StatesManufacturer1October 2, 2017000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer1November 2, 1994000api.fda.gov
Medtronic Powered Surgical SolutionsFort Worth, TX, United StatesManufacturer1December 31, 2014000api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer1May 3, 2001000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer1August 11, 2010000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor1June 27, 2002010api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1February 26, 2010000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer1May 3, 2001000api.fda.gov
Neauvia North America, IncRaleigh, NC, United StatesComplaint file establishment, Specification developer1January 17, 2023000api.fda.gov
New Deantronics, Ltd.Sparks, NV, United StatesManufacturer1March 31, 2006000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesManufacturer, Repackager or relabeler1July 28, 1981000api.fda.gov
Pavmed, Inc.Foxborough, MA, United StatesSpecification developer1April 20, 2020000api.fda.gov
Prosurg, IncSan Jose, CA, United StatesManufacturer1November 12, 1996000api.fda.gov
RG Medical USAMount Juliet, TN, United StatesRepackager or relabeler, Specification developer1November 2, 1994000api.fda.gov
Silex Medical, LLCSouthington, CT, United StatesManufacturer1January 6, 1992010api.fda.gov
Single Pass, Inc.Lake Forest, CA, United StatesManufacturer, Manufacturer for export1April 25, 2024000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer1July 27, 2004000api.fda.gov
Surgical Principals, Inc. - SpiTacoma, WA, United StatesContract manufacturer, Specification developer1August 16, 2021000api.fda.gov
Surgical Technology Laboratories Inc.Lugoff, SC, United StatesManufacturer1April 14, 2017000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Minnetonka, MN, United StatesManufacturer1January 28, 2009000api.fda.gov
Thermosurgery Technologies, Inc.Mesa, AZ, United StatesSpecification developer1February 1, 2007000api.fda.gov
Titan Manufacturing Inc.Fall River, MA, United StatesComplaint file establishment, Manufacturer1October 25, 2021000api.fda.gov
U.S. Surgitech, Inc.Carol Stream, IL, United StatesSpecification developer1April 29, 1991000api.fda.gov
Urologix, LLCPlymouth, MN, United StatesManufacturer1November 15, 2012010api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer1September 5, 2006010api.fda.gov
3M CompanyValley, NE, United StatesContract manufacturer0000api.fda.gov
AB Medical Technologies, Inc.Redding, CA, United StatesContract manufacturer0000api.fda.gov
Apical InstrumentsRedwood City, CA, United StatesContract manufacturer0000api.fda.gov
Applied Medical CoatingsLockport, NY, 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
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer0000api.fda.gov
Ascentron, Inc.White City, OR, United StatesContract manufacturer0000api.fda.gov
Aulea Medical, Inc.Pleasanton, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Antron Engineering & Machine Co, IncBellingham, MA, United StatesContract manufacturer0000api.fda.gov
Arthrex California Technology, IncorporatedSanta Barbara, CA, 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
Augustine Temperature Management, LLCMinnetonka, MN, United StatesManufacturer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Rochester, MN, United StatesContract manufacturer0000api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesContract manufacturer0000api.fda.gov
Bioventus LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract manufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
CogmedixWest Boylston, MA, United StatesContract manufacturer0000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
Contract Medical Manufacturing, LLCOxford, CT, United StatesContract manufacturer0000api.fda.gov
Cirtec MedicalEnfield, CT, United StatesContract manufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Custom Manufacturing Inc.Elbert, CO, United StatesContract manufacturer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
EndoplusMundelein, IL, United StatesContract manufacturer0000api.fda.gov
Express Manufacturing, IncSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Freudenberg Medical, LLCJeffersonville, IN, United StatesContract manufacturer0000api.fda.gov
Galvanize TherapeuticsRedwood City, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
General Vibronics, Inc.Tempe, AZ, United StatesManufacturer0000api.fda.gov
Gmi CorporationFranklin, IN, United StatesContract manufacturer0000api.fda.gov
Grace Manufacturing IncRussellville, AR, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
Heat In A Click LLCDania, FL, United StatesSpecification developer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Implant Logistics / AMS MicromedicalSparta, WI, United StatesContract manufacturer0000api.fda.gov
Intuitive Surgical, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
Jabil Inc.Auburn Hills, MI, 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
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer0000api.fda.gov
M4D LLCLake Forest, CA, United StatesContract manufacturer0000api.fda.gov
Mack Molding CompanyArlington, VT, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Meddux Development Corporation LLCBoulder, CO, United StatesContract manufacturer0000api.fda.gov
Midwest Products And EngineeringMilwaukee, WI, United StatesContract manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Misonix, LLCFarmingdale, NY, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Modo IncHillsboro, OR, United StatesContract manufacturer0000api.fda.gov
Medeologix LLCSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Medivators IncMinneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Micro Stamping CorporationSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Modo, Inc.McMinnville, OR, United StatesContract manufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Northeast Scientific, Inc.Waterbury, CT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
Nypro Healthcare Baja Inc. (Albuquerque)Albuquerque, NM, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Parker Laboratories, Inc.Fairfield, NJ, United StatesContract manufacturer0000api.fda.gov
Phase-N CorporationBoston, MA, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Neenah, WI, United StatesContract manufacturer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Production Systems, Inc.Shoreview, MN, 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
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTechOlathe, KS, United StatesContract manufacturer0000api.fda.gov
Rdi Inc.Mount Kisco, NY, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Renovo, Inc.Bend, OR, United StatesReprocessor0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Sage Product Development, Inc.Foxborough, MA, United StatesContract manufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Stellartech Research Corp.Milpitas, CA, United StatesContract manufacturer0000api.fda.gov
Tecan Cdmo Solutions MH, Corp.Morgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesContract manufacturer0000api.fda.gov
The Brewer Company LLCMenomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Vein360Blue Ash, OH, United StatesReprocessor0000api.fda.gov
VestaFranklin, WI, United StatesContract manufacturer0000api.fda.gov
Velentium MedicalRichmond, TX, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, United StatesContract manufacturer0000api.fda.gov
Zinnanti Surgical Design Group IncSanta Cruz, CA, United StatesSpecification developer0000api.fda.gov

Updated November 3, 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.