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Data / Medical devices / Splint, Hand, And Components / United States

FDA-registered makers of Splint, Hand, And Components in the United States: 97 establishments

97 establishments in the United States are registered with the FDA to make Splint, Hand, And Components (product code ILH). 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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Device
Splint, Hand, And Components
Product code
ILH
Country
United States

Makers of Splint, Hand, And Components in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3-Point Products, Inc.Stevensville, MD, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Air A Med, LLCFort Myers, FL, United StatesSpecification developer0000api.fda.gov
Akervall TechnologiesSaline, MI, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Alex Orthopedic, Inc.Grand Prairie, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Alimed, LLCDedham, MA, United StatesSpecification developer0000api.fda.gov
Angular Ortho, LLCMequon, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Apothecary Products, LLC.Burnsville, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Ar Orthopedics, LLCNewberry, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ats InnovationsCookeville, TN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Atulo ProductsNewton, MA, United StatesManufacturer0000api.fda.gov
Action PackagingWoodstock, IL, United StatesSpecification developer0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
Becker Orthopedic Appliance Co.Troy, MI, United StatesManufacturer0000api.fda.gov
Benik Corp.Silverdale, WA, United StatesManufacturer0000api.fda.gov
Biosculptor CorporationHialeah, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Border Opportunity Saver Systems, Inc.Del Rio, TX, United StatesContract manufacturer0000api.fda.gov
Braceability, Inc.Cedar Falls, IA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bauerfeind USA, INC.Atlanta, GA, United StatesSpecification developer0000api.fda.gov
BrownmedSpirit Lake, IA, United StatesManufacturer0000api.fda.gov
Carolina Narrow Fabric Co.Winston-Salem, NC, United StatesContract manufacturer0000api.fda.gov
Comforback IncAuburndale, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Comfortland International, LLCMebane, NC, United StatesSpecification developer0000api.fda.gov
Core Products Intl., Inc.Osceola, WI, United StatesSpecification developer0000api.fda.gov
Darco International, Inc.Huntington, WV, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Dynasplint Systems, Inc.Stevensville, MD, United StatesManufacturer0000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
E. Bac Si Imports LLCEllensburg, WA, United StatesSpecification developer0000api.fda.gov
Elastic Therapy, LLCAsheboro, NC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Elite Orthopaedics, Inc.South El Monte, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Flint Rehabilitation Devices, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
G-Force BracesManchester, NH, United StatesSpecification developer0000api.fda.gov
Grace And Able I IncSnohomish, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Greenwood Marketing LLCBrandenburg, KY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Hartmann Usa Inc.Rock Hill, SC, United StatesSpecification developer0000api.fda.gov
Higgins Supply Co., Inc.McGraw, NY, United StatesManufacturer0000api.fda.gov
Hely & WeberDfw, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ideavillage Products Corp.Wayne, NJ, United StatesSpecification developer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Jaeco OrthopedicHot Springs, AR, United StatesManufacturer0000api.fda.gov
Joint Jack CompanyFarmington, CT, United StatesManufacturer0000api.fda.gov
Kenad SG Medical, Inc.Bartlett, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Kinetec UsaJackson, WI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Klarity Medical Products, LLCHeath, OH, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
La Pointique International Ltd.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Lay Low Enterprises LLCVirginia Beach, VA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Life Wear Technologies, Inc.Pompano Beach, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Manamed LLCDenton, TX, United StatesSpecification developer0000api.fda.gov
Mckie Splints, LLCDuluth, MN, United StatesManufacturer0000api.fda.gov
Medical Specialties, Inc.Wadesboro, NC, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Mobility Braces, LLCNorth Salt Lake, UT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0010api.fda.gov
NYOrthoBrooklyn, NY, United StatesManufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Optec Usa, Inc.Lawrenceville, GA, United StatesManufacturer0000api.fda.gov
Orthomerica Products, Inc.Orlando, FL, United StatesManufacturer0000api.fda.gov
Orthopress Inc.Austin, TX, United StatesManufacturer0000api.fda.gov
Performance Health Supply, LLC.Cedarburg, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Preferred Industries, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Puritan Medical Products Company LLCGuilford, ME, United StatesManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Restorative Care Of America, Inc.Saint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Richardson Products, Inc.Frankfort, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Secured Ortho Manufacturing Of America, LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Silver Ring Splint Co.Charlottesville, VA, United StatesManufacturer0000api.fda.gov
Span Link International LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Splint Factory Corp.Port Townsend, WA, United StatesManufacturer, Specification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
The Soule CoLutz, FL, United StatesManufacturer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesManufacturer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesManufacturer0000api.fda.gov
Trend Medical, LLCBethlehem, PA, United StatesSpecification developer0000api.fda.gov
Tenacious Holdings IncSaint Paul, MN, United StatesSpecification developer0000api.fda.gov
Tender CorporationLittleton, NH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Thuasne, LLCBakersfield, CA, United StatesManufacturer, Specification developer0000api.fda.gov
U.S. Orthotics, Inc.Tampa, FL, United StatesManufacturer0000api.fda.gov
United Surgical LLCLaotto, IN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
VHA Office of Advanced Manufacturing - Ft. LawtonSeattle, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Welly Health PBCMinneapolis, MN, United StatesSpecification developer0000api.fda.gov
Wendy Taylor MedeirosPahoa, HI, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Xo Armor Technologies IncAuburn, AL, United StatesManufacturer, Specification 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.