openFDA UDI API — Medical Device Database

Search the FDA Unique Device Identifier (UDI) database by device name, manufacturer, GMDN term, FDA product code, or GS1/HIBCC/ICCBBA identifier. Returns brand, model, manufacturer, MRI safety, GMDN terms, and FDA product codes. Built for medical device vendors, hospital procurement, and AI agents that need to ground device questions.

Free trial

A free Apify account gives you about 5 USD of monthly credits, more than enough to resolve hundreds of devices and inspect the JSON schema before paying.

Use cases

1. Device recall watch — given a brand name (e.g. "CocoBear"), pull every version's is_discontinued and commercial_distribution_status.
2. Hospital procurement lookup — given a GS1 DI, fetch mri_safety_class, first_product_code_name, and first_medical_specialty for a procurement decision.
3. LLM medical device QA — answer user queries about MRI safety by returning the top 5 records filtered by brand or model number.

Input

{
  "brand_name": "CocoBear",
  "company_name": "",
  "gmdn_term_name": "",
  "max_results": 20
}

Field	Type	Default	Description
brand_name	string	""	Partial brand-name match (case-insensitive).
company_name	string	""	Partial company-name match (case-insensitive).
version_or_model_number	string	""	Model/version number.
gmdn_term_name	string	""	GMDN term (e.g. Thermometer).
first_product_code	string	""	FDA product code (e.g. FLL).
first_medical_specialty	string	""	FDA medical specialty.
is_discontinued	boolean	false	Only discontinued records.
is_in_commercial_distribution	boolean	false	Only currently distributed devices.
max_results	integer	50	Cap on returned devices.

Output (real run)

[
  {
    "public_device_record_key": "b959e12b-023c-4c4d-a7f3-305f6d985826",
    "brand_name": "CocoBear Non-contact Infrared Thermometer",
    "company_name": "Alicn Medical Shenzhen, Inc.",
    "labeler_duns_number": "548040741",
    "version_or_model_number": "AET-R1B1-B",
    "device_count_in_base_package": 1,
    "commercial_distribution_status": "In Commercial Distribution",
    "public_version_number": "2",
    "public_version_date": "2020-12-04",
    "record_status": "Published",
    "is_discontinued": false,
    "is_in_commercial_distribution": true,
    "is_single_use": false,
    "is_sterile": false,
    "is_kit": false,
    "is_otc": false,
    "is_rx": false,
    "is_rx_or_otc": false,
    "is_combination_product": false,
    "is_hct_p": false,
    "is_direct_marking_exempt": false,
    "has_donation_id_number": false,
    "has_expiration_date": false,
    "has_lot_or_batch": false,
    "has_manufacturing_date": false,
    "has_mri_safety_info": false,
    "has_serial": false,
    "mri_safety": "Labeling does not contain MRI Safety Information",
    "mri_safety_class": null,
    "first_product_code": "FLL",
    "first_product_code_name": "Thermometer, Electronic, Clinical",
    "first_medical_specialty": "General Hospital",
    "first_regulation_number": "880.2910",
    "gmdn_term_count": 1,
    "gmdn_terms": ["Thermometer, infrared, skin"],
    "issuing_agencies": ["GS1"],
    "identifier_count": 1,
    "identifier_types": ["Primary"],
    "first_identifier_id": "06958866334019",
    "first_identifier_type": "Primary",
    "customer_contact_count": 1,
    "product_code_count": 1,
    "product_code_names": ["Thermometer, Electronic, Clinical"],
    "product_codes": ["FLL"],
    "medical_specialty_descriptions": ["General Hospital"],
    "version_age_days": 1966
  }
]

Field	Type	Description
public_device_record_key	string	UDI record UUID.
brand_name / company_name	string	Brand and labeler.
labeler_duns_number	string	DUNS of the labeler.
version_or_model_number	string	Model/version.
commercial_distribution_status	string	In Commercial Distribution, Not in Commercial Distribution.
public_version_date	string	Date of the public record version.
record_status	string	Published or other.
is_discontinued / is_in_commercial_distribution / is_single_use / is_sterile / is_kit / is_otc / is_rx / is_combination_product / is_hct_p / is_direct_marking_exempt	boolean	Convenience flags.
has_donation_id_number / has_expiration_date / has_lot_or_batch / has_manufacturing_date / has_mri_safety_info / has_serial	boolean	Identifier presence flags.
mri_safety	string	Free-text MRI safety label.
mri_safety_class	string	MR Safe, MR Conditional, MR Unsafe, or null.
first_product_code / first_product_code_name	string	FDA product code and name.
first_medical_specialty	string	FDA medical specialty.
first_regulation_number	string	21 CFR part (e.g. 880.2910).
gmdn_term_count / gmdn_terms	integer / array	Global Medical Device Nomenclature terms.
issuing_agencies	array	GS1, HIBCC, ICCBBA.
identifier_count / identifier_types	integer / array	Identifier metadata.
first_identifier_id / first_identifier_type	string	Primary device identifier.
customer_contact_count	integer	Customer contact entries.
product_code_count / product_code_names / product_codes	integer / array	All product codes.
medical_specialty_descriptions	array	Specialty strings.
version_age_days	integer	Age of this version since public_version_date.

Pricing (pay-per-event)

• No subscription. Free monthly credits apply first.
• 1 result = $0.001 USD (about $1 per 1 000 results).
• Charged per item returned in the dataset; failed runs are not charged.

Source, licence, limits

• Source: openFDA UDI database (/device/udi.json).
• Licence: CC0 1.0 — public domain dedication.
• Update frequency: openFDA refreshes the UDI dataset monthly; this Actor reflects the upstream API at the moment of the run.
• Limits: openFDA caps each request at 1 000 records; we paginate up to max_results. Spelling for company_name is best-effort.

FAQ

How do I look up a device by GS1 barcode? Pass the barcode in first_identifier_id. Use exact match (no spaces or hyphens).

What's a GMDN term? Global Medical Device Nomenclature — an international taxonomy. Use gmdn_term_name for human-friendly filtering.

What's the difference between mri_safety and mri_safety_class? mri_safety is the free-text label FDA submitted; mri_safety_class is the structured MR Safe / MR Conditional / MR Unsafe value (or null when not provided).

Why are some records is_discontinued=true? Devices remain in the database after the manufacturer stops distributing them. Filter by is_in_commercial_distribution=true for the active catalogue.

Why is labeler_duns_number sometimes empty? Some labelers (notably outside the US) do not provide a DUNS.

How do I find devices in a single product category? Use first_product_code (e.g. FLL for clinical electronic thermometers).

Other Actors from DevOne-Studio

• ted-tenders-api — TED (Tenders Electronic Daily) EU public procurement search.
• pdf-to-text-api — PDF to text + tables extraction via pdfplumber, no external calls.
• pubmed-articles-api — NCBI PubMed biomedical literature with MeSH/DOI/year filters.
• federal-register-api — US federal agency rules, proposed rules, notices, presidential docs.
• sec-company-tickers — Resolve SEC CIK from ticker or company name (10,400+ issuers).
• sec-edgar-fulltext-search-api — Full-text search across 35M+ SEC EDGAR filings and exhibits.
• sec-edgar-xbrl-frames-api — XBRL frames (Revenues, Assets, NetIncomeLoss) for ~6000 US issuers.
• cfpb-consumer-complaints-api — 18M+ US CFPB consumer complaints since 2011.
• nhtsa-safety-ratings-api — NHTSA NCAP 5-star vehicle safety ratings.
• eia-state-electricity-api — US state-level electricity generation and consumption, 1990-2025.

Changelog

• 2026-10-12 — SEO metadata (seoTitle, seoDescription); README rewritten with real output sample, FAQ, cross-links.
• 2026-10-05 — Pricing switched to Apify pay-per-event ($0.001 per dataset item).
• 2026-09-30 — Initial public release on the Apify Store.