IVD, Diagnostics and Surgical Devices (FDA / EU regulated device makers)

Where this market publishes its structure

• openFDA device/510k (api.fda.gov, keyless; advisory_committee CH HE IM MI PA TX SU OR, decision_date >= 2016) machine-readable, 11,499 decisions / 3,065 applicants; 70 linked
• openFDA device/pma (same panels, >= 2016) machine-readable, 6,012 decisions (originals + supplements) / 150 applicants; 20 linked
• openFDA device/registrationlisting (owner/operator count by medical specialty, top 1,000 per specialty) machine-readable, 3,586 owner/operators; 60 linked; regulated, no certified products
• FDA CLIA test categorization database (accessdata.fda.gov/premarket/ftparea/clia_detail.zip; the cfClia search page's download) machine-readable, 81,132 rows / 1,060 test-system makers; 33 linked
• EUDAMED public API (ec.europa.eu/tools/eudamed/api devices/udiDiData IVDR + eos manufacturers + actor publicInformation) machine-readable, 95,526 IVDR UDI-DI records / 896 manufacturers; 13 linked; most big makers file under regional legal entities the name check refuses
• AdvaMedDx members (advamed.org/advameddx/members) machine-readable, 65 members with website; 22 linked; 4 held (distributor, contract manufacturer, 2 investors)
• EUDAMED notified-body certificates / actor search by role not machine-readable: eos endpoint 500s without languageIso2Code; certificate data is not in the public actor view (2026-10-21)
• cfClia search.cfm results not machine-readable: a POST form; the same data is published as clia_detail.zip, which was read instead

Own = declares at least one integration itself; covered = visible only because an aggregator, standards body, regulator or partner contract names it; distribution-only = listed only on cloud marketplaces it sells through, a channel reported beside, never counted as its own declared integrations; undeclared = nothing we can read, so no number; declares_compatibility = providers with a `compatible` shape vote, report only (kin, 2026-10-13): never counted as own, never in depth or position.

Taxonomy how this market maps onto apis.io

Derived 2026-10-21 from the 129 providers in this market we could resolve in the catalog. The percentage is the share of those providers carrying each one; it describes the market, not the tag or industry. Tag groups have no page of their own yet, so they are listed unlinked.

share of resolved cohort carrying it; tags >=0.20 & >=3 members (max 12, junk dropped), tag_groups >=0.20 (cooccurrence, non-cross-cutting; max 8), industries >=0.20 (max 6), areas >=0.10 (max 6; areas are keyword-matched and sparse), capabilities L1 >=0.20 (max 8); derive-market-taxonomy.py

Leaders by position (provisional)

Provisional: grouped by position, depth compared within a position only. Distribution (cloud marketplaces) and iPaaS bridges are counted beside position, never inside it. Unknown-builder listings are left out of position shares and counted here.

coverage 2 · reaches banks, carriers, systems or channels (an aggregator)

regulated 98 · named in a regulator's register or partners' contracts

standard 13 · listed by a voluntary standard's own directory

distribution 2 · only sells through cloud marketplaces

undeclared 14 · declares nothing we can read: no number