Lead type · openFDA device clearances

FDA device clearance leads

A new FDA 510(k) clearance or PMA approval is granted.

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A new FDA 510(k) clearance or PMA approval is granted

openFDA device clearances · weekly

What it is

The signal

A 510(k) clearance or PMA approval marks a device maker bringing a product to market — a commercialization moment for contract manufacturers, sterilization, packaging, reimbursement and sales-enablement vendors.

On the record

Fields this signal carries

Every field is read verbatim off the underlying public record — observational, never inferred or fabricated.

applicant companydevice / 510(k) numberclearance typedecision date

Sample

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Who buys it

Teams that use this lead type

Contract device manufacturers and sterilization vendors
Reimbursement and regulatory consultants
Med-device competitive-intelligence teams

Signals that pair with this one

FDA drug approval leads

A new FDA drug approval or supplement is granted to an applicant company

FDA recall leads

An FDA drug or device recall / enforcement report names a recalling firm

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Build a Parse on this signal, edit the states and filters, and get an alert whenever a new record fits — by email, webhook or Zapier.

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