FDA 510(k) Clearance Leads (New Medical Devices)
Pricing
from $3.00 / 1,000 results
FDA 510(k) Clearance Leads (New Medical Devices)
Newly cleared U.S. medical devices from the official openFDA 510(k) API: applicant company, contact name, address, device name, product code, advisory committee, decision date. Filter by state, product code, specialty; monitor mode for medtech sales leads.
Pricing
from $3.00 / 1,000 results
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Open Data Tools
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2
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1
Monthly active users
5 days ago
Last modified
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Security
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When FDA clears a 510(k), the applicant company just proved a new (or modified) device is substantially equivalent. That is a high-intent medtech lead: they need contract manufacturing, sterilization, packaging, labeling, reimbursement consulting, distributors, and capital.
This actor pulls new clearances from the official openFDA 510(k) API with applicant name, contact, address, device name, product code, and advisory committee.
Who uses this
- Medtech CDMO / contract manufacturers and sterilizers
- Regulatory and reimbursement consultants
- Device distributors and sales agencies
- Investors and BD teams tracking competitive clearances
- Software/tools that alert sales teams to new K-numbers
Why this actor
- Official source: openFDA
device/510k(FDA). No key for normal volumes. - Lead-ready fields: applicant, contact name, street address, city/state/ZIP.
- Filters: decision-date window, state, product code, advisory committee, clearance type, US-only, require contact.
- Monitor mode:
onlyNewSinceLastRunfor scheduled feeds. - Pay per result.
Input examples
US clearances last 30 days in CA/MA/MN with a contact name:
Neurology (NE) devices, last 90 days:
Legal
openFDA data is public; follow https://open.fda.gov/terms/ and https://open.fda.gov/license/. Do not present the data as FDA advice. Lawful B2B lead gen and research only.
