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Data / Medical devices / Mallet / United States

FDA-registered makers of Mallet in the United States: 89 establishments

89 establishments in the United States are registered with the FDA to make Mallet (product code HXL). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Get makers of this device in the United StatesWatch these makers
Device
Mallet
Product code
HXL
Country
United States

Makers of Mallet in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
4web Inc.Frisco, TX, United StatesSpecification developer0000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer0000api.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
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Black & Black Surgical, Inc.Tucker, GA, United StatesSpecification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
CAPTIVA SPINE, Inc.Jupiter, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Disruptive Medtech, LLCLaramie, WY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Elevation SpineMonterey, CA, United StatesSpecification developer0000api.fda.gov
Elliquence LLCBaldwin, NY, United StatesSpecification developer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Flospine LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
H & H Co.Hayden, ID, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Hu-Friedy MFG Co., LLCDes Plaines, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesManufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Implant Resource, Inc.Eagan, MN, United StatesSpecification developer0010api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Kirwan Surgical Products, LLC.Marshfield, MA, United StatesManufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Medartis Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
NanoHive Medical LLCWoburn, MA, United StatesManufacturer, Specification developer0000api.fda.gov
NuVasive Specialized Orthopedics, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesManufacturer for export0000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Osseus Fusion Systems LLCDallas, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Precision Medical Manufacturing LLCWheeling, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing FacilityN Manchester, IN, United StatesContract manufacturer0000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer0000api.fda.gov
Rayco Steel Process, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesSpecification developer0000api.fda.gov
S.S. White Technologies, Inc. / Dba Shukla MedicalSt Petersburg, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
Sterramed IncWeehawken, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Thompson MisSandown, NH, United StatesSpecification developer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
rms SurgicalAnoka, MN, 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.