{
  "openapi": "3.0.1",
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    "title": "FDA Device Establishment Leads via openFDA",
    "description": "FDA medical device establishment leads from registration and listing data via openFDA: makers, contract manufacturers, sterilizers and relabelers. Filter by state, country, type, product code, class, specialty. Firm-level only: no personal names, phones or emails. $3/1,000. Not affiliated with FDA.",
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  "components": {
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      "inputSchema": {
        "type": "object",
        "properties": {
          "countries": {
            "title": "Countries",
            "type": "array",
            "description": "Two-letter ISO country codes of the establishment address, e.g. US, CA, DE, CN. Empty = all countries.",
            "default": [
              "US"
            ],
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              "type": "string"
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          },
          "states": {
            "title": "US states",
            "type": "array",
            "description": "Optional. Two-letter codes or US state names of the establishment address, e.g. TX, CA, Minnesota. Empty = all states.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "establishmentTypes": {
            "title": "Establishment types",
            "type": "array",
            "description": "Which FDA establishment operations to include (any of them). Empty = all types.",
            "items": {
              "type": "string",
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                "manufacturer",
                "contract_manufacturer",
                "contract_sterilizer",
                "repackager_relabeler",
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                "complaint_file",
                "foreign_exporter",
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                "single_use_reprocessor",
                "foreign_private_label_distributor"
              ],
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                "Contract manufacturers (make devices for another party)",
                "Contract sterilizers",
                "Repackagers / relabelers",
                "Specification developers (design, do not manufacture)",
                "Complaint file establishments",
                "Foreign exporters to the US",
                "US manufacturers for export only",
                "Remanufacturers",
                "Single-use device reprocessors",
                "Foreign private label distributors"
              ]
            },
            "default": [
              "contract_manufacturer"
            ]
          },
          "productCodes": {
            "title": "FDA product codes",
            "type": "array",
            "description": "Optional. Three-letter FDA device product codes, e.g. FRO (wound dressing), DXT, LLZ. Look codes up in FDA's Product Classification database. Empty = all products.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "deviceClasses": {
            "title": "Device classes",
            "type": "array",
            "description": "Optional. Keep firms listing at least one device in these classes. Empty = all classes.",
            "items": {
              "type": "string",
              "enum": [
                "1",
                "2",
                "3",
                "U",
                "N",
                "F"
              ],
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                "Class II (moderate risk)",
                "Class III (high risk, PMA)",
                "Unclassified",
                "Not classified",
                "HDE (humanitarian device exemption)"
              ]
            },
            "default": []
          },
          "medicalSpecialties": {
            "title": "Medical specialties (device panels)",
            "type": "array",
            "description": "Optional. FDA regulation medical specialty of the listed devices, e.g. Orthopedic, Dental, Cardiovascular. Empty = all.",
            "items": {
              "type": "string",
              "enum": [
                "Anesthesiology",
                "Cardiovascular",
                "Clinical Chemistry",
                "Clinical Toxicology",
                "Dental",
                "Ear, Nose, Throat",
                "Gastroenterology, Urology",
                "General Hospital",
                "General, Plastic Surgery",
                "Hematology",
                "Immunology",
                "Medical Genetics",
                "Microbiology",
                "Neurology",
                "Obstetrics/Gynecology",
                "Ophthalmic",
                "Orthopedic",
                "Pathology",
                "Physical Medicine",
                "Radiology",
                "Unknown"
              ]
            },
            "default": []
          },
          "companyName": {
            "title": "Company name contains",
            "type": "string",
            "description": "Optional. Word or phrase matched against the establishment name and the owner/operator company name, e.g. medtronic or \"argon medical\"."
          },
          "onlyInitialImporters": {
            "title": "Only initial importers",
            "type": "boolean",
            "description": "Keep only establishments flagged by FDA as initial importers.",
            "default": false
          },
          "maxResults": {
            "title": "Max results (establishments)",
            "minimum": 1,
            "maximum": 50000,
            "type": "integer",
            "description": "Stop after this many establishment leads. Each saved row is one $0.003 lead.",
            "default": 100
          },
          "maxProductsPerRow": {
            "title": "Max products per row",
            "minimum": 1,
            "maximum": 500,
            "type": "integer",
            "description": "Cap on the products, device names, brand names and premarket numbers listed per row. productCodes and medicalSpecialties are always complete for the listings that matched your filters.",
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          },
          "maxApiCalls": {
            "title": "Max openFDA calls per run",
            "minimum": 1,
            "maximum": 1000,
            "type": "integer",
            "description": "Safety cap. Each call reads up to 1,000 listing records. Without a key, openFDA allows 1,000 calls per day per IP address.",
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          },
          "openFdaApiKey": {
            "title": "Your openFDA API key (optional)",
            "type": "string",
            "description": "Optional. Not needed: the Actor works without a key. If you have your own free openFDA key, add it to use openFDA's higher daily limit."
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        }
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