US Tech Automations

Other dated records weekly, every Wednesday Sample ready

FDA device establishment changes, one national file a week

Device distributors, initial importers, and hospital supply-chain compliance desks get one weekly national file of every FDA device-establishment change. and 12 October 2026, 24 device establishments appeared on the FDA register, 20 stopped being listed, and 152 changed a detail. Every one is in the file; the first rows of each kind are printed below with the two export dates they came from.

Price
No pay button yet
Built for
Device distributors and initial importers who must prove a foreign manufacturer or importer is still FDA-registered; product-liability insurers; hospital supply-chain compliance desks
Cadence
one national file a week, built from the Monday FDA export and the one before it. A week that changes nothing is sent as 0 plus the two export dates
Public sample
Prepared, not yet on sale

Ask about this fileNo card needed to ask. We reply with what we hold.

Establishments that stopped being listed between 5 October 2026 and 12 October 202620 establishments

The FDA publishes its whole device establishment register and overwrites it every week. We seal a dated copy and compare it with the one before. These 20 registrations are in the 5 October 2026 copy and not in the 12 October 2026 one. Whether the firm closed, let its registration lapse, or the FDA rebuilt its file, we did not see and will not imply.

12 of the 20 that stopped being listed 5 October 2026 to 12 October 2026
RegistrationBusinessCityStateCountryWhat it does
1037998Sanmina, Huntsville, ALHUNTSVILLEALUSManufacture Device in the United States for Export Only;Manufacture Medical Device for Another Party (Contract Manufacturer)
1050138Microbiologics, Inc.LEXINGTONKYUSManufacture Medical Device for Another Party (Contract Manufacturer)
1422681SYSMEX AMERICA, INC.MundeleinILUSManufacture Medical Device
1430016Dik Fulfillment Services INCLockportILUSRepack or Relabel Medical Device
2919069ABBOTT LABORATORIESSunnyvaleCAUSDevelop Specifications But Do Not Manufacture At This Facility
3007207906NEO MEDICAL INC.SparksNVUSDevelop Specifications But Do Not Manufacture At This Facility;Manufacture Medical Device
3008156050DIVERSILABSJim ThorpePAUSManufacture Medical Device
3008818980ICU Medical, Inc.Olive BranchMSUSManufacture Medical Device
3010676465Litex Manufacturing, Inc.GlendaleCAUSManufacture Medical Device;Manufacture Medical Device for Another Party (Contract Manufacturer)
3010742884Otsuka America Pharmaceutical, IncHaywardCAUSDevelop Specifications But Do Not Manufacture At This Facility
3011237704ICU Medical Czech Republic a. s.Hranice Olomoucky KrajCZManufacture Medical Device
3013847376Peytant SolutionsPlymouthMNUSComplaint File Establishment per 21 CFR 820.198;Manufacture Medical Device

Establishments that appeared between 5 October 2026 and 12 October 202624 establishments

In the 12 October 2026 copy and not in the 5 October 2026 one. New manufacturers, importers and repackagers, at home and abroad, the week they show up.

12 of the 24 that appeared 5 October 2026 to 12 October 2026
RegistrationBusinessCityStateCountryWhat it does
3003205477BENEV COMPANY INCMission ViejoCAUSComplaint File Establishment per 21 CFR 820.198
3011537276STROKE HOLDER INC.Las VegasNVUSDevelop Specifications But Do Not Manufacture At This Facility
3016873039WAVE NEUROSCIENCENewport BeachCAUSManufacture Medical Device
3027543194HEALTHY HAIR INCVistaCAUSRepack or Relabel Medical Device
3034881464GRAVITAS MEDICAL, INC.BerkeleyCAUSComplaint File Establishment per 21 CFR 820.198;Manufacture Medical Device
3038493956ResMed Motor Technologies IncCalabasasCAUSManufacture Medical Device for Another Party (Contract Manufacturer)
3041123877ATFC LIMITEDOshawa OntarioCAExport Device to the United States But Perform No Other Operation on Device
3042655017ARCHY DENTAL, INC.San JoseCAUSManufacture Medical Device
3043712029Spiro Robotics Inc.HaywardCAUSComplaint File Establishment per 21 CFR 820.198;Develop Specifications But Do Not Manufacture At This Facility
3044466298EMBOLINE INCSanta CruzCAUSComplaint File Establishment per 21 CFR 820.198;Manufacture Medical Device;Repack or Relabel Medical Device
3046274075CARBON, INC.SunnyvaleCAUSComplaint File Establishment per 21 CFR 820.198;Develop Specifications But Do Not Manufacture At This Facility
3046548163ALCOVE MEDICAL, INC.Cedar CityUTUSManufacture Medical Device

Establishments whose details changed152 establishments

Same registration, different detail: a new owner number, a changed status, a move to another city or country, a different set of operations, or a new expiry year. The file names the fields that changed on every row.

12 of the 152 that changed 5 October 2026 to 12 October 2026
RegistrationBusinessCityStateCountryWhat it doesChanged
1037007GYRUS ACMI, INC.BARTLETTTNUSDevelop Specifications But Do Not Manufacture At This Facility;Manufacture Medical Device;Repack or Relabel Medical Deviceproduct_code_count
1038963BSN medical Inc.CHARLOTTENCUSComplaint File Establishment per 21 CFR 820.198;Develop Specifications But Do Not Manufacture At This Facilityname
1043534WRIGHT MEDICAL TECHNOLOGY, INC.ArlingtonTNUSManufacture Device in the United States for Export Only;Manufacture Medical Device;Manufacture Medical Device for Another Party (Contract Manufacturer);Repack or Relabel Medical Deviceproduct_code_count
1062741SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)BIRMINGHAMALUSDevelop Specifications But Do Not Manufacture At This Facility;Manufacture Medical Device;Repack or Relabel Medical Deviceproduct_code_count
1121091Manus Medical, LLCHenricoVAUSManufacture Medical Device;Repack or Relabel Medical Deviceestablishment_types, product_code_count
1223843BICON, LLCBostonMAUSComplaint File Establishment per 21 CFR 820.198;Develop Specifications But Do Not Manufacture At This Facility;Manufacture Medical Device;Repack or Relabel Medical Deviceproduct_code_count
1226348Cerenovus, Inc.RAYNHAMMAUSManufacture Device in the United States for Export Only;Manufacture Medical Deviceproduct_code_count
1314492Baxter Healthcare CorporationMEDINANYUSDevelop Specifications But Do Not Manufacture At This Facility;Manufacture Medical Deviceestablishment_types
1319660ISOMEDIX OPERATIONS INC.CHESTERNYUSManufacture Device in the United States for Export Only;Sterilize Medical Device for Another Party (Contract Sterilizer)product_code_count
1319744SAFETEC OF AMERICA, INC.BUFFALONYUSManufacture Medical Device;Repack or Relabel Medical Deviceproduct_code_count
1423537Cardinal Health 200, LLCWaukeganILUSComplaint File Establishment per 21 CFR 820.198product_code_count
1424263Isomedix Operations, Inc.LibertyvilleILUSManufacture Device in the United States for Export Only;Sterilize Medical Device for Another Party (Contract Sterilizer)product_code_count

What you get

  • One national CSV every WednesdayEstablishments that appeared, stopped being listed, or changed since the previous weekly FDA export. Every country in one file.
  • Fourteen columnsExport date, FEI number, registration number, owner number, business name, city, state, country, what the site does, status, expiry year, how many product codes it lists, what kind of change, and which fields changed. No street address, no phone, no person's name.
  • The two export dates in every rowSo a row can be checked against the FDA register on the day.
  • An honest empty weekA week with no changes is sent as 0 plus the two export dates. A week where the FDA file could not be read says so instead of repeating the last one.

The sample on this page spans 7 days, not one week. The FDA overwrites its export every week and keeps no history. The oldest dated copy we could obtain is 5 October 2026, so the first comparison covers 5 October 2026 to 12 October 2026. Weekly files start with the first pair of copies we seal ourselves, one week apart.

The FDA gives the register away. You can download the whole file free at open.fda.gov any week. What you are paying for is the comparison: the dated copy it overwrote, and the list of what moved between the two. Registration is not FDA approval, and a row that stopped being listed is not proof of closure or of anything the FDA decided.

Newest copy read 12 October 2026. Rows from copies with missing identifiers, conflicting duplicates, or spreadsheet-unsafe values are left out and counted, never guessed.

See the file before you pay

You do not have to take our word for what is in the file. Here are 25 rows of the real thing, carrying all 14 of its columns, cut out of the dated copies we sealed ourselves. Nothing in it is made up and nothing in it is tidied up.

  • Open the 25 rows as a CSVA plain spreadsheet file. It saves to your machine rather than painting itself into a browser tab, and it opens in Excel, Numbers or Google Sheets.
  • The same 25 rows as JSONThe same rows again, laid out for reading with code.

The file is prepared and not yet on sale.

These 25 rows are a slice of the file, not the whole of it. What we cannot show you here is how far back it goes: that is the part you are paying for.

Start the thread

No pay button on this one yet. Email operations@ustechautomations.com. The file is prepared and not yet on sale. Ask which dated copies we hold. We reply with the count of appeared, gone and changed rows for the newest pair.

Ask about this file

The file is prepared and not yet on sale.

Refunds: if what you receive is not what the page describes, email operations@ustechautomations.com within 7 days for a full refund. Support: same address, replies within 2 business days.