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Data / Medical devices / United States / Nomax, Inc.

Nomax, Inc.: FDA-registered device maker in Affton, MO, United States, 5 510(k) clearances

Nomax, Inc. is registered with the FDA (registration 1937310) in Affton, MO, United States. It lists 25 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 16, 2010. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1937310
Address
9735 Green Park Industrial Drive, Affton, MO, United States, 63123
Owner or operator
NOMAX, INC. (1937310)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
July 22, 1992
Registered through
2026
Brand names listed
AMCON Deepwell Flat Pack, Amcon Alcohol Prep Pad, Amcon Fit-In Post-Myds, Amcon Lens-Eze, Amcon Nitrile PF Exam Gloves, Amcon Royal Remover, Amcon Slip-In Post-Myds, Barraquer Wire Lid Speculum Loop, Adult and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Soft Lens ProductsLPN2Repackager or relabeleraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Contract manufactureraccessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Repackager or relabeleraccessdata.fda.gov
Case, Contact LensLRX2Contract manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Subsystem, Water PurificationNIH2Contract manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Inserter/Remover Contact LensKYE1Manufactureraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Repackager or relabeleraccessdata.fda.gov
Lens, Spectacle, Non-Custom (Prescription)HQG1Repackager or relabeleraccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Repackager or relabeleraccessdata.fda.gov
Pack, Heat, MoistIMA1Repackager or relabeleraccessdata.fda.gov
Plaque Disclosing KitNYH2Contract manufactureraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Prism, GonioscopicHKS1Repackager or relabeleraccessdata.fda.gov
Prism, Rotary, OphthalmicHKQ1Repackager or relabeleraccessdata.fda.gov
Retractor, EntKAL1Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeleraccessdata.fda.gov
Set, Lens, Trial, OphthalmicHPC1Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Strip, SchirmerKYD1Manufacturer, Specification developeraccessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)HQY1Repackager or relabeleraccessdata.fda.gov
Tester, Color VisionHIT1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 16, 2010K100439MEDIWORKS SLIT LAMPHJOSubstantially EquivalentShanghai Mediworks Precision Instruments Co. , Ltd.accessdata.fda.gov
September 6, 2007K071910NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)LZASubstantially EquivalentHartalega Sdn Bhdaccessdata.fda.gov
April 13, 2005K050517JSZ-MULTIPURPOSE SOLUTIONLPNSubstantially EquivalentSzabocsik and Associatesaccessdata.fda.gov
June 6, 2000K991206BONASSE CONTACT LENS CASELRXSubstantially EquivalentBonasse Ent. Co., Ltd.accessdata.fda.gov
May 12, 1993K923458CONTACT LENS CASELRXSubstantially EquivalentNomax, Inc.accessdata.fda.gov

Compare with other makers

Updated July 16, 2010. 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.