{
  "family": "fda-device-establishment-week",
  "generated": "2026-09-08",
  "note": "Real rows out of dated copies we sealed ourselves. Nothing here is made up.",
  "where_these_rows_came_from": "Where these rows came from, and anything their publisher requires to be printed alongside them, is set out on the page this file came from: https://ustechautomations.com/feeds/fda-device-establishment-week",
  "rows_published": 25,
  "columns": 14,
  "headers": [
    "week_ending",
    "fei_number",
    "registration_number",
    "owner_operator_number",
    "name",
    "city",
    "state_code",
    "iso_country_code",
    "establishment_types",
    "status_code",
    "reg_expiry_date_year",
    "product_code_count",
    "change",
    "changed_fields"
  ],
  "rows": [
    [
      "2026-09-07",
      "1000036852",
      "1000036852",
      "10091394",
      "Astellas Pharma US, Inc.",
      "Northbrook",
      "IL",
      "US",
      "Complaint File Establishment per 21 CFR 820.198;Manufacture Medical Device",
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      "2026",
      "1",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "1000163068",
      "1000163068",
      "8031539",
      "SB-KAWASUMI LABORATORIES, INC.",
      "Kawasaki-shi Kanagawa",
      "",
      "JP",
      "Develop Specifications But Do Not Manufacture At This Facility",
      "1",
      "2026",
      "11",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "1000164532",
      "1000164532",
      "10088928",
      "Yamato Scale Co., LTD",
      "Akashi Hyogo",
      "",
      "JP",
      "Manufacture Medical Device",
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      "2026",
      "1",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "1000015879",
      "1033422",
      "9001775",
      "KIMBERLY-CLARK CORPORATION",
      "Roswell",
      "GA",
      "US",
      "Complaint File Establishment per 21 CFR 820.198;Develop Specifications But Do Not Manufacture At This Facility",
      "1",
      "2026",
      "4",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "1287329",
      "1287329",
      "9106359",
      "Sequel Special Products d.b.a Nissha Medical Technologies",
      "Wolcott",
      "CT",
      "US",
      "Manufacture Medical Device for Another Party (Contract Manufacturer)",
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      "2026",
      "14",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "1000136007",
      "1528764",
      "9006978",
      "SPECTRAMED, LLC",
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      "Develop Specifications But Do Not Manufacture At This Facility",
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      "2026",
      "2",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "1000117854",
      "1645362",
      "9005876",
      "Movair, Inc.",
      "Austin",
      "TX",
      "US",
      "Manufacture Medical Device",
      "1",
      "2026",
      "1",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "1824231",
      "1824231",
      "8020727",
      "ICU Medical, Inc.",
      "Gary",
      "IN",
      "US",
      "Manufacture Medical Device",
      "1",
      "2026",
      "6",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "2020703",
      "2020703",
      "2020703",
      "WYKLE RESEARCH, INC.",
      "CARSON CITY",
      "NV",
      "US",
      "Complaint File Establishment per 21 CFR 820.198;Manufacture Medical Device;Repack or Relabel Medical Device",
      "1",
      "2026",
      "6",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "2025881",
      "2025881",
      "2025881",
      "PRESSURE PRODUCTS, INC.",
      "Santa Barbara",
      "CA",
      "US",
      "Complaint File Establishment per 21 CFR 820.198;Develop Specifications But Do Not Manufacture At This Facility",
      "1",
      "2026",
      "2",
      "vanished",
      ""
    ],
    [
      "2026-09-07",
      "1000121375",
      "1000121375",
      "10090292",
      "SUMMERS LABORATORIES INC.",
      "Collegeville",
      "PA",
      "US",
      "Repack or Relabel Medical Device",
      "1",
      "2026",
      "1",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "1000486410",
      "1000486410",
      "10094027",
      "KNOWLES ELECTRONICS (MALAYSIA) SDN. BHD.",
      "BAYAN LEPAS Pulau Pinang",
      "",
      "MY",
      "Manufacture Medical Device for Another Party (Contract Manufacturer)",
      "1",
      "2026",
      "1",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "1037039",
      "1037039",
      "1037039",
      "QED, INC.",
      "LEXINGTON",
      "KY",
      "US",
      "Manufacture Medical Device",
      "1",
      "2026",
      "4",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "1039671",
      "1039671",
      "1039671",
      "SWEAT INSTITUTE",
      "Atlanta",
      "GA",
      "US",
      "Manufacture Medical Device",
      "1",
      "2026",
      "1",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "1000112898",
      "1044143",
      "1044143",
      "PETER SCHIFF ENTERPRISE",
      "COOKEVILLE",
      "TN",
      "US",
      "Manufacture Medical Device",
      "1",
      "2026",
      "2",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "1052243",
      "1052243",
      "1052243",
      "MACBRUD CORP., MEDICAL DIVISION",
      "Crossings",
      "FL",
      "US",
      "Manufacture Medical Device",
      "1",
      "2026",
      "1",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "3003457476",
      "1067085",
      "9047881",
      "AMBRA LE ROY, LLC",
      "CHARLOTTE",
      "NC",
      "US",
      "Repack or Relabel Medical Device",
      "1",
      "2026",
      "2",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "1219392",
      "1219392",
      "1219276",
      "ACCUSYNC MEDICAL RESEARCH CORP.",
      "Trumbull",
      "CT",
      "US",
      "Manufacture Medical Device",
      "1",
      "2026",
      "1",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "1220018",
      "1220018",
      "1220018",
      "SONTEK MEDICAL, LLC",
      "Rochester",
      "NH",
      "US",
      "Develop Specifications But Do Not Manufacture At This Facility",
      "1",
      "2026",
      "2",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "3001237338",
      "1225492",
      "9026654",
      "NextPhase Medical Devices LLC",
      "ROCHESTER",
      "NH",
      "US",
      "Manufacture Medical Device for Another Party (Contract Manufacturer);Repack or Relabel Medical Device",
      "1",
      "2026",
      "18",
      "appeared",
      ""
    ],
    [
      "2026-09-07",
      "1000121056",
      "1000121056",
      "9912058",
      "Boston Scientific Corporation",
      "Coventry",
      "RI",
      "US",
      "Develop Specifications But Do Not Manufacture At This Facility;Manufacture Device in the United States for Export Only;Manufacture Medical Device",
      "1",
      "2026",
      "124",
      "changed",
      "establishment_types;product_code_count"
    ],
    [
      "2026-09-07",
      "3004393730",
      "1000150646",
      "9924008",
      "Wyeth Pharmaceuticals LLC",
      "Collegeville",
      "PA",
      "US",
      "Complaint File Establishment per 21 CFR 820.198",
      "1",
      "2026",
      "3",
      "changed",
      "product_code_count"
    ],
    [
      "2026-09-07",
      "1000165971",
      "1000165971",
      "9059364",
      "MicroPort CRM S.r.l.",
      "Saluggia (VC)      Vercelli",
      "",
      "IT",
      "Export Device to the United States But Perform No Other Operation on Device;Manufacture Medical Device;Repack or Relabel Medical Device",
      "1",
      "2026",
      "12",
      "changed",
      "city"
    ],
    [
      "2026-09-07",
      "1000172127",
      "1000172127",
      "9027281",
      "DELTA S.R.L.",
      "DOMEGGE Di CADORE      Belluno",
      "",
      "IT",
      "Manufacture Medical Device",
      "1",
      "2026",
      "2",
      "changed",
      "city"
    ],
    [
      "2026-09-07",
      "1000181154",
      "1000181154",
      "9031117",
      "BARCO S.R.L.",
      "Saronno      Varese",
      "",
      "IT",
      "Manufacture Medical Device;Manufacture Medical Device for Another Party (Contract Manufacturer)",
      "1",
      "2026",
      "6",
      "changed",
      "city"
    ]
  ]
}