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Data / Medical devices / Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use / United States

FDA-registered makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use in the United States: 76 establishments

76 establishments in the United States are registered with the FDA to make Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (product code LXG). 0 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.

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Device
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Product code
LXG
Country
United States

Makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abbott LaboratoriesAbbott Park, IL, United StatesManufacturer for export0000api.fda.gov
Abbott Molecular, Inc.Des Plaines, IL, United StatesManufacturer for export0000api.fda.gov
Apostle Inc.Pleasanton, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Awareness Technology, Inc.Palm City, FL, United StatesManufacturer0000api.fda.gov
Abbott Diagnostics Scarborough, Inc.Scarborough, ME, United StatesSpecification developer0000api.fda.gov
Abbott Molecular Distribution CenterItasca, IL, United StatesManufacturer for export0000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Baxter Healthcare CorporationCleveland, MS, United StatesManufacturer0000api.fda.gov
BCD And AssociatesIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Bio SB, Inc.Santa Barbara, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Biocare Medical, LLCPacheco, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Biogenex Laboratories Inc.Fremont, CA, United StatesManufacturer0000api.fda.gov
Biomerieux, Inc.Hazelwood, MO, United StatesManufacturer0010api.fda.gov
Biomedical Polymers, Inc.Sterling, MA, United StatesManufacturer0010api.fda.gov
Cole InstrumentsAlpharetta, GA, United StatesComplaint file establishment, Remanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Copan Diagnostics, Inc.Murrieta, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Covaris, LLCWoburn, MA, United StatesManufacturer0000api.fda.gov
Cyvek, Inc.Wallingford, CT, United StatesManufacturer for export0000api.fda.gov
Carclo Technical Plastics - LatrobeLatrobe, PA, United StatesContract manufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Daxor CorporationOak Ridge, TN, United StatesManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesSpecification developer0000api.fda.gov
Dynex Technologies, Inc.Chantilly, VA, United StatesComplaint file establishment, Manufacturer0020api.fda.gov
Domico Med-Device, LLCFenton, MI, United StatesManufacturer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Fenwal, Inc.Lake Zurich, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Fresenius Kabi WarrendaleWarrendale, PA, United StatesManufacturer0000api.fda.gov
FormaPath, Inc.Ithaca, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesBuffalo, NY, United StatesContract manufacturer0000api.fda.gov
Grifols Diagnostic Solutions Inc.San Diego, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hardy DiagnosticsOrcutt, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer0000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer0010api.fda.gov
HELMER Inc.Noblesville, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Ims Engineered Products, LLCDes Plaines, IL, United StatesContract manufacturer0000api.fda.gov
LCR Hallcrest, LLC. (IL)Glenview, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
LGC Clinical Diagnostics, Inc.Milford, MA, United StatesManufacturer0000api.fda.gov
LGC Clinical Diagnostics, Inc.Cumberland Foreside, ME, United StatesManufacturer0000api.fda.gov
Leavitt Medical, Inc.Lehi, UT, United StatesManufacturer0000api.fda.gov
Leica Biosystems Richmond, Inc.Richmond, IL, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler0000api.fda.gov
Mika Metal Fabraicating Co.Willoughby, OH, United StatesContract manufacturer0000api.fda.gov
Mlife Diagnostics LLCMarshall, TX, United StatesManufacturer0000api.fda.gov
Molded Products Inc.Harlan, IA, United StatesManufacturer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer0000api.fda.gov
Nico CorporationIndianapolis, IN, United StatesSpecification developer0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Porex CorporationFairburn, GA, United StatesManufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Prince Sterilization Services, LLCFairfield, NJ, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Roche Molecular Systems, Inc.Branchburg, NJ, United StatesSpecification developer0000api.fda.gov
Ranfac Corp.Avon, MA, United StatesManufacturer0000api.fda.gov
Roche Diagnostics Santa ClaraSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
Sakura Finetek U.s.a., Inc.Torrance, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
ScigeneSanta Clara, CA, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Smart PracticePhoenix, AZ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Sysmex America, Inc.Buffalo Grove, IL, United StatesManufacturer0000api.fda.gov
Sysmex America, Inc. - Vernon HillsVernon Hills, IL, United StatesManufacturer0000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer0000api.fda.gov
Thermo Fisher Scientific (asheville) LLCMarietta, OH, United StatesContract manufacturer0000api.fda.gov
Trademark Plastics Inc.Riverside, CA, United StatesSpecification developer0000api.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
The Vollrath Company LLCKiel, WI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
ThermoGenesis Corp.Rancho Cordova, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Ventana Medical Systems, Inc.Tucson, AZ, United StatesManufacturer0000api.fda.gov
Vollrath Company LLC, TheSheboygan, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Wavesense, Inc.Irvine, CA, United StatesManufacturer0000api.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.