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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Laboratories | Abbott Park, IL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apostle Inc. | Pleasanton, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Awareness Technology, Inc. | Palm City, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Molecular Distribution Center | Itasca, IL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Cleveland, MS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BCD And Associates | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio SB, Inc. | Santa Barbara, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biocare Medical, LLC | Pacheco, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biogenex Laboratories Inc. | Fremont, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux, Inc. | Hazelwood, MO, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Biomedical Polymers, Inc. | Sterling, MA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cole Instruments | Alpharetta, GA, United States | Complaint file establishment, Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Diagnostics, Inc. | Murrieta, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covaris, LLC | Woburn, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cyvek, Inc. | Wallingford, CT, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carclo Technical Plastics - Latrobe | Latrobe, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Daxor Corporation | Oak Ridge, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynex Technologies, Inc. | Chantilly, VA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Fenton, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FormaPath, Inc. | Ithaca, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grifols Diagnostic Solutions Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| HELMER Inc. | Noblesville, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ims Engineered Products, LLC | Des Plaines, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LCR Hallcrest, LLC. (IL) | Glenview, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LGC Clinical Diagnostics, Inc. | Milford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LGC Clinical Diagnostics, Inc. | Cumberland Foreside, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leavitt Medical, Inc. | Lehi, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Richmond, Inc. | Richmond, IL, United States | Complaint file establishment, Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mika Metal Fabraicating Co. | Willoughby, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mlife Diagnostics LLC | Marshall, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Molded Products Inc. | Harlan, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nico Corporation | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Porex Corporation | Fairburn, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prince Sterilization Services, LLC | Fairfield, NJ, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ranfac Corp. | Avon, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics Santa Clara | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Finetek U.s.a., Inc. | Torrance, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scigene | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smart Practice | Phoenix, AZ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermo Fisher Scientific (asheville) LLC | Marietta, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Vollrath Company LLC | Kiel, WI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| ThermoGenesis Corp. | Rancho Cordova, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventana Medical Systems, Inc. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vollrath Company LLC, The | Sheboygan, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wavesense, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.