> ## Documentation Index
> Fetch the complete documentation index at: https://docs.oneshotagent.com/llms.txt
> Use this file to discover all available pages before exploring further.
# FDA Establishment Registration
> Look up medical device establishments, their registration status, activities and listed devices.
Covers medical device establishments registered with the US Food and Drug Administration, worldwide. Supply exactly one registration number, FEI number or firm name. A name search may match many establishments of one group; country narrows name searches only. registration\_year is the year the registration runs to. Groups up to 100 source listings into establishments, in first-seen order. Products are unique by product code, at most 25 per establishment, newest created date first; duplicate codes use the newest listing’s details. When truncated is true, only the first 100 source listings are considered: product lists may be incomplete, and name searches may omit entire establishments. Named contacts are excluded. No match returns an empty list. The source refreshes weekly; the evidence date identifies its snapshot.
## Authentication
Requires x402 payment in the `payment-signature` header.
## Request Body
**registration\_number** `string`
The establishment’s FDA registration number.
**fei\_number** `string`
The FDA establishment identifier.
**firm\_name** `string`
Firm name phrase; only letters, digits, spaces, ampersands, hyphens, periods and commas are kept. 2 to 100 characters.
**country** `string`
Two-letter ISO country code; narrows firm name searches only.
**limit** `integer`
The most establishments to return. From 1 to 10. Defaults to `3`.
## Response (200 OK)
Top-level envelope: `success` (boolean) and `data` (object). All fields below are nested under `data`.
**data.request\_id** `string`
Durable job ID for audit and lookup
**data.status** `string`
Job status: `completed`
**data.tool** `string`
Always `company_fda_registration`
**data.result** `object`
The answer, described under Result below
**data.evidence** `object`
Where the answer came from and when
**data.evidence.source** `string`
The public body the data comes from. Always `US Food and Drug Administration`.
**data.evidence.source\_kind** `string`
`public` when the data comes from a public body, `commercial` otherwise
**data.evidence.retrieved\_at** `string`
When the lookup was made, as an ISO 8601 UTC time
**data.evidence.as\_of** `string`
When the source says the fact was last updated, or `null` when the source gives no date
## Result
Nested under `data.result`.
**data.result.total\_listings** `integer`
Total matching source listings, including those beyond the first 100.
**data.result.truncated** `boolean`
More than 100 source listings matched; only the first 100 are considered, so product lists may be incomplete and name searches may omit entire establishments.
**data.result.establishments** `object[]`
Matching establishments in first-seen order.
**data.result.establishments\[].registration\_number** `string`
Registration number.
**data.result.establishments\[].fei\_number** `string`
The FDA Establishment Identifier (FEI). `null` when the source gives no value.
**data.result.establishments\[].name** `string`
Name. `null` when the source gives no value.
**data.result.establishments\[].address** `object`
Address.
**data.result.establishments\[].address.street** `string`
Street. `null` when the source gives no value.
**data.result.establishments\[].address.city** `string`
City. `null` when the source gives no value.
**data.result.establishments\[].address.state** `string`
State. `null` when the source gives no value.
**data.result.establishments\[].address.postal\_code** `string`
Postal code. `null` when the source gives no value.
**data.result.establishments\[].address.country** `string`
Country. `null` when the source gives no value.
**data.result.establishments\[].registration\_year** `integer`
The year the registration runs to; null when absent.
**data.result.establishments\[].active** `boolean`
Active.
**data.result.establishments\[].initial\_importer** `boolean`
Initial importer.
**data.result.establishments\[].owner\_operator** `object`
The establishment’s owner-operator.
**data.result.establishments\[].owner\_operator.number** `string`
Number. `null` when the source gives no value.
**data.result.establishments\[].owner\_operator.firm\_name** `string`
Firm name. `null` when the source gives no value.
**data.result.establishments\[].owner\_operator.city** `string`
City. `null` when the source gives no value.
**data.result.establishments\[].owner\_operator.state** `string`
State. `null` when the source gives no value.
**data.result.establishments\[].owner\_operator.country** `string`
Country. `null` when the source gives no value.
**data.result.establishments\[].activities** `string[]`
Unique establishment activities across the returned listings.
**data.result.establishments\[].products** `object[]`
Unique product codes, newest listing first, at most 25.
**data.result.establishments\[].products\[].product\_code** `string`
Product code. `null` when the source gives no value.
**data.result.establishments\[].products\[].device\_name** `string`
Device name. `null` when the source gives no value.
**data.result.establishments\[].products\[].device\_class** `string`
Device class. `null` when the source gives no value.
**data.result.establishments\[].products\[].medical\_specialty** `string`
Medical specialty. `null` when the source gives no value.
**data.result.establishments\[].products\[].regulation\_number** `string`
Regulation number. `null` when the source gives no value.
**data.result.establishments\[].products\[].clearance** `string`
The listing’s clearance or premarket approval number, when present. `null` when the source gives no value.
**data.result.establishments\[].products\[].proprietary\_names** `string[]`
Proprietary names.
```bash cURL theme={null}
curl -X POST https://win.oneshotagent.com/v1/tools/lookup/company-fda-registration \
-H "Content-Type: application/json" \
-H "payment-signature: " \
-d '{
"registration_number": "1030489"
}'
```
```javascript JavaScript theme={null}
const response = await fetch("https://win.oneshotagent.com/v1/tools/lookup/company-fda-registration", {
method: "POST",
headers: {
"Content-Type": "application/json",
"payment-signature": paymentProof,
},
body: JSON.stringify({
"registration_number": "1030489"
}),
});
```
```typescript SDK theme={null}
const result = await agent.tool('lookup/company-fda-registration', {
registration_number: '1030489'
});
console.log(result.result);
console.log(result.evidence);
```
```json Response (200) theme={null}
{
"success": true,
"data": {
"request_id": "uuid",
"receipt_id": "rcpt_...",
"status": "completed",
"tool": "company_fda_registration",
"result": {
"total_listings": 533,
"truncated": true,
"establishments": [
{
"registration_number": "1030489",
"fei_number": "1000477302",
"name": "MEDTRONIC SOFAMOR DANEK USA, INC.",
"address": {
"street": "1800 PYRAMID PLACE",
"city": "Memphis",
"state": "TN",
"postal_code": "38132",
"country": "US"
},
"registration_year": 2026,
"active": true,
"initial_importer": true,
"owner_operator": {
"number": "2112641",
"firm_name": "Medtronic, Inc.",
"city": "Minneapolis",
"state": "MN",
"country": "US"
},
"activities": [
"Develop Specifications But Do Not Manufacture At This Facility"
],
"products": [
{
"product_code": "MAX",
"device_name": "Intervertebral Fusion Device With Bone Graft, Lumbar",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3080",
"clearance": "K253011",
"proprietary_names": [
"Catalyft PL Expandable Interbody System"
]
},
{
"product_code": "NKB",
"device_name": "Thoracolumbosacral Pedicle Screw System",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3070",
"clearance": "K260216",
"proprietary_names": [
"CD Horizon ModuLeX Spinal System",
"CD Horizon ModuLeX Fenestrated Screw Set"
]
},
{
"product_code": "KWP",
"device_name": "Appliance, Fixation, Spinal Interlaminal",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3050",
"clearance": "K260216",
"proprietary_names": [
"CD Horizon ModuLeX Spinal System",
"CD Horizon ModuLeX Fenestrated Screw Set"
]
},
{
"product_code": "KWQ",
"device_name": "Appliance, Fixation, Spinal Intervertebral Body",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3060",
"clearance": "K260216",
"proprietary_names": [
"CD Horizon ModuLeX Spinal System",
"CD Horizon ModuLeX Fenestrated Screw Set"
]
},
{
"product_code": "NKG",
"device_name": "Posterior Cervical Screw System",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3075",
"clearance": "K254165",
"proprietary_names": [
"INFINITY Occipitocervical Upper Thoracic System"
]
},
{
"product_code": "OLO",
"device_name": "Orthopedic Stereotaxic Instrument",
"device_class": "2",
"medical_specialty": "Neurology",
"regulation_number": "882.4560",
"clearance": "K254165",
"proprietary_names": [
"INFINITY Occipitocervical Upper Thoracic System"
]
},
{
"product_code": "OVD",
"device_name": "Intervertebral Fusion Device With Integrated Fixation, Lumbar",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3080",
"clearance": "K241992",
"proprietary_names": [
"Catalyft LS Expandable Interbody System"
]
},
{
"product_code": "OSH",
"device_name": "Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3070",
"clearance": null,
"proprietary_names": [
"Spinal System"
]
},
{
"product_code": "MNH",
"device_name": "Orthosis, Spondylolisthesis Spinal Fixation",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3070",
"clearance": null,
"proprietary_names": [
"Spinal System"
]
},
{
"product_code": "MNI",
"device_name": "Orthosis, Spinal Pedicle Fixation",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3070",
"clearance": null,
"proprietary_names": [
"Spinal System"
]
},
{
"product_code": "HBE",
"device_name": "Drills, Burrs, Trephines & Accessories (Simple, Powered)",
"device_class": "2",
"medical_specialty": "Neurology",
"regulation_number": "882.4310",
"clearance": "K210637",
"proprietary_names": [
"CD Horizon ModuLeX Spinal System"
]
},
{
"product_code": "NQP",
"device_name": "Posterior Metal/Polymer Spinal System, Fusion",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3070",
"clearance": "K191066",
"proprietary_names": [
"CD Horizon Astute Spinal System"
]
},
{
"product_code": "ODP",
"device_name": "Intervertebral Fusion Device With Bone Graft, Cervical",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3080",
"clearance": "K153438",
"proprietary_names": [
"PERIMETER® C"
]
},
{
"product_code": "MQP",
"device_name": "Spinal Vertebral Body Replacement Device",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3060",
"clearance": "K131888",
"proprietary_names": [
"T2 XVBR"
]
},
{
"product_code": "NPM",
"device_name": "Bone Grafting Material, Animal Source",
"device_class": "2",
"medical_specialty": "Dental",
"regulation_number": "872.3930",
"clearance": "K140374",
"proprietary_names": [
"MASTERGRAFT Putty"
]
},
{
"product_code": "LYC",
"device_name": "Bone Grafting Material, Synthetic",
"device_class": "2",
"medical_specialty": "Dental",
"regulation_number": "872.3930",
"clearance": "K140374",
"proprietary_names": [
"MASTERGRAFT Putty"
]
},
{
"product_code": "OVE",
"device_name": "Intervertebral Fusion Device With Integrated Fixation, Cervical",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3080",
"clearance": "K142940",
"proprietary_names": [
"Endoskeleton TCS System"
]
},
{
"product_code": "MQV",
"device_name": "Filler, Bone Void, Calcium Compound",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.3045",
"clearance": "K130335",
"proprietary_names": [
"Mastergraft ( UltraMatrix, Matrix EXT)"
]
},
{
"product_code": "HWE",
"device_name": "Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment",
"device_class": "1",
"medical_specialty": "General, Plastic Surgery",
"regulation_number": "878.4820",
"clearance": "K123270",
"proprietary_names": [
"POWEREASE System Working Ends"
]
},
{
"product_code": "GWF",
"device_name": "Stimulator, Electrical, Evoked Response",
"device_class": "2",
"medical_specialty": "Neurology",
"regulation_number": "882.1870",
"clearance": "K123270",
"proprietary_names": [
"POWEREASE System Working Ends"
]
},
{
"product_code": "NUN",
"device_name": "Bone Grafting Material, Human Source",
"device_class": "2",
"medical_specialty": "Dental",
"regulation_number": "872.3930",
"clearance": "K051188",
"proprietary_names": [
"Grafton DBM"
]
},
{
"product_code": "HRX",
"device_name": "Arthroscope",
"device_class": "2",
"medical_specialty": "Orthopedic",
"regulation_number": "888.1100",
"clearance": "K103231",
"proprietary_names": [
"Kyphon Inflation Syringe"
]
},
{
"product_code": "HXG",
"device_name": "Tamp",
"device_class": "1",
"medical_specialty": "Orthopedic",
"regulation_number": "888.4540",
"clearance": "K103231",
"proprietary_names": [
"Kyphon Inflation Syringe"
]
},
{
"product_code": "NEK",
"device_name": "Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction",
"device_class": "3",
"medical_specialty": "Unknown",
"regulation_number": null,
"clearance": "P000058",
"proprietary_names": [
"INFUSE BONEGRAFT/ LT-CAGE Lumbar TF"
]
},
{
"product_code": "NQO",
"device_name": "Prosthesis, Spinous Process Spacer/Plate",
"device_class": "3",
"medical_specialty": "Unknown",
"regulation_number": null,
"clearance": "P040001",
"proprietary_names": [
"X-STOP® Interspinous Spacer Titanium"
]
}
]
}
]
},
"evidence": {
"source": "US Food and Drug Administration",
"source_kind": "public",
"retrieved_at": "2026-10-21T00:00:00.000Z",
"calls": [
{
"retrieved_at": "2026-10-21T00:00:00.000Z"
}
],
"as_of": "2026-10-12"
}
}
}
```
> [!NOTE]
>
> See [Pricing](https://docs.oneshotagent.com/pricing.md) for this tool's price. A wallet (x402) call receives it in the 402 quote before anything is charged; a call paid from prepaid credits is charged when the API accepts the request and answers `200`.
## Notes
* Results return inline. The finished job stays available at `/v1/requests/{request_id}`
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