US Tech Automations

Other dated records weekly, every Wednesday Sample ready

FDA device establishment changes, one national file a week

Between 1 May 2026 and 7 September 2026, 1,338 device establishments appeared on the FDA register, 129 stopped being listed, and 5,163 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
$49/mo
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
Sample ready

Email us for the $49/mo checkout linkNo card needed to ask. We reply with what we hold.

Establishments that stopped being listed between 1 May 2026 and 7 September 2026129 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 129 registrations are in the 1 May 2026 copy and not in the 7 September 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 129 that stopped being listed 1 May 2026 to 7 September 2026
RegistrationBusinessCityStateCountryWhat it does
1000036852Astellas Pharma US, Inc.NorthbrookILUSComplaint File Establishment per 21 CFR 820.198;Manufacture Medical Device
1000163068SB-KAWASUMI LABORATORIES, INC.Kawasaki-shi KanagawaJPDevelop Specifications But Do Not Manufacture At This Facility
1000164532Yamato Scale Co., LTDAkashi HyogoJPManufacture Medical Device
1033422KIMBERLY-CLARK CORPORATIONRoswellGAUSComplaint File Establishment per 21 CFR 820.198;Develop Specifications But Do Not Manufacture At This Facility
1287329Sequel Special Products d.b.a Nissha Medical TechnologiesWolcottCTUSManufacture Medical Device for Another Party (Contract Manufacturer)
1528764SPECTRAMED, LLCGahannaOHUSDevelop Specifications But Do Not Manufacture At This Facility
1645362Movair, Inc.AustinTXUSManufacture Medical Device
1824231ICU Medical, Inc.GaryINUSManufacture Medical Device
2020703WYKLE RESEARCH, INC.CARSON CITYNVUSComplaint File Establishment per 21 CFR 820.198;Manufacture Medical Device;Repack or Relabel Medical Device
2025881PRESSURE PRODUCTS, INC.Santa BarbaraCAUSComplaint File Establishment per 21 CFR 820.198;Develop Specifications But Do Not Manufacture At This Facility
2133929CARESTREAM HEALTH, INC.Landfall VillageMNUSDevelop Specifications But Do Not Manufacture At This Facility
2135346CULLIGAN SOFT WATER SERVICE CO.MinnetonkaMNUSManufacture Medical Device

Establishments that appeared between 1 May 2026 and 7 September 20261,338 establishments

In the 7 September 2026 copy and not in the 1 May 2026 one. New manufacturers, importers and repackagers, at home and abroad, the week they show up.

12 of the 1,338 that appeared 1 May 2026 to 7 September 2026
RegistrationBusinessCityStateCountryWhat it does
1000121375SUMMERS LABORATORIES INC.CollegevillePAUSRepack or Relabel Medical Device
1000486410KNOWLES ELECTRONICS (MALAYSIA) SDN. BHD.BAYAN LEPAS Pulau PinangMYManufacture Medical Device for Another Party (Contract Manufacturer)
1037039QED, INC.LEXINGTONKYUSManufacture Medical Device
1039671SWEAT INSTITUTEAtlantaGAUSManufacture Medical Device
1044143PETER SCHIFF ENTERPRISECOOKEVILLETNUSManufacture Medical Device
1052243MACBRUD CORP., MEDICAL DIVISIONCrossingsFLUSManufacture Medical Device
1067085AMBRA LE ROY, LLCCHARLOTTENCUSRepack or Relabel Medical Device
1219392ACCUSYNC MEDICAL RESEARCH CORP.TrumbullCTUSManufacture Medical Device
1220018SONTEK MEDICAL, LLCRochesterNHUSDevelop Specifications But Do Not Manufacture At This Facility
1225492NextPhase Medical Devices LLCROCHESTERNHUSManufacture Medical Device for Another Party (Contract Manufacturer);Repack or Relabel Medical Device
1420088IRONWOOD INDUSTRIES, INC.LIBERTYVILLEILUSManufacture Medical Device for Another Party (Contract Manufacturer)
1430016Dik Fulfillment Services INCLockportILUSRepack or Relabel Medical Device

Establishments whose details changed5,163 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 5,163 that changed 1 May 2026 to 7 September 2026
RegistrationBusinessCityStateCountryWhat it doesChanged
1000121056Boston Scientific CorporationCoventryRIUSDevelop Specifications But Do Not Manufacture At This Facility;Manufacture Device in the United States for Export Only;Manufacture Medical Deviceestablishment_types, product_code_count
1000150646Wyeth Pharmaceuticals LLCCollegevillePAUSComplaint File Establishment per 21 CFR 820.198product_code_count
1000165971MicroPort CRM S.r.l.Saluggia (VC) VercelliITExport Device to the United States But Perform No Other Operation on Device;Manufacture Medical Device;Repack or Relabel Medical Devicecity
1000172127DELTA S.R.L.DOMEGGE Di CADORE BellunoITManufacture Medical Devicecity
1000181154BARCO S.R.L.Saronno VareseITManufacture Medical Device;Manufacture Medical Device for Another Party (Contract Manufacturer)city
1000189446LA GIARDINIERA SRLVENEGONO INFERIORE VareseITForeign Private Label Distributor;Manufacture Medical Devicecity
1000202462AB MEDICA GROUP S. A.Barcelona BarcelonaESManufacture Medical Devicecity
1000203163GROSFILLEY LUNETTES S.A.S.OYONNAX AinFRExport Device to the United States But Perform No Other Operation on Device;Manufacture Medical Devicecity
1000204638LEICA INSTRUMENTS (SINGAPORE) PTE LTD.SINGAPORE South WestSGManufacture Medical Device;Manufacture Medical Device for Another Party (Contract Manufacturer)establishment_types, product_code_count
1000206206TECHNOGENETICS SPALODI LodiITManufacture Medical Devicecity
1000206677ROPOX A/SNaestved SjaellandDKComplaint File Establishment per 21 CFR 820.198;Manufacture Medical Devicecity
1000221288HK KOLMAR USA, LLCOlyphantPAUSDevelop Specifications But Do Not Manufacture At This Facility;Manufacture Medical Device;Manufacture Medical Device for Another Party (Contract Manufacturer)name

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 129 days, not one week. The FDA overwrites its export every week and keeps no history. The oldest dated copy we could obtain is 1 May 2026, so the first comparison covers 1 May 2026 to 7 September 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 7 September 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.

What arrives after you pay: a person emails you the whole file as a CSV — the same plain spreadsheet as the sample file above, not a login and not a web page — within one working day of your payment.

What you would be paying for: $49 a month, billed monthly, for one national file a week: every FDA device establishment that appeared on the register since the previous weekly export, every one that stopped being listed, and every one whose details changed, with the fields that changed named. Fourteen columns; no street address, phone or person. Cancel any time by email. After you pay, a person emails you the current week's file as a CSV within one working day, then a new one every Wednesday for as long as the subscription runs. Each file names the two export dates it was built from. A week where we could not read the FDA file says so rather than repeating the last one.

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. Ask which dated copies we hold. We reply with the count of appeared, gone and changed rows for the newest pair before you spend anything.

What you would be paying for: $49 a month, billed monthly, for one national file a week: every FDA device establishment that appeared on the register since the previous weekly export, every one that stopped being listed, and every one whose details changed, with the fields that changed named. Fourteen columns; no street address, phone or person. Cancel any time by email. After you pay, a person emails you the current week's file as a CSV within one working day, then a new one every Wednesday for as long as the subscription runs. Each file names the two export dates it was built from. A week where we could not read the FDA file says so rather than repeating the last one.

Email us for the $49/mo checkout link

We tell you the row counts and the two export dates before you pay.