Regulatory research · Knowledge

The FDA’s databases,
indexed for humans.

Every FDA database, guidance document, and international standard — unified, searchable, and cited in-product. Stop opening seven browser tabs to answer one question.

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FDA

510(k) Database

Every cleared 510(k) since 1976 — searchable by device type, product code, applicant, decision date, and similarity score.

800,000+ decisions indexed · Updated daily
FDA

MAUDE

Manufacturer and User Facility Device Experience — all MDR event reports, failure modes mapped, and cross-referenced to your device type.

15M+ reports · Rolling 10-year window
FDA

Classification Database

Full product classification database with 21 CFR mapping, product codes, special controls, and device class — all queryable in plain English.

1,700+ device categories
FDA

Guidance Documents

All current and draft FDA guidance documents, cross-referenced to device type, submission pathway, and applicable standards.

4,000+ guidance documents
FDA

Recall Database

All Class I, II, and III device recalls — searchable by cause, device type, firm, and voluntary vs. mandatory. Track your device category's recall history.

Updated weekly
EU/International

EUDAMED

European database for medical devices — for companies managing EU MDR compliance alongside FDA submissions. UDI, notified body decisions, and vigilance reports.

EU MDR · EU IVDR
One search. All sources.

Ask once. Get results from everywhere.

Type a device name, product code, or regulatory question. Knowledge searches all connected sources simultaneously and returns ranked, citation-ready results.

  • Cross-source deduplication — no more sifting through redundant results
  • Similarity scoring — results ranked by relevance to your device profile
  • One-click citation — add any result directly to your submission draft
Search
510(k)
K211045 — Steerable Ablation Catheter
Biosense Webster · Cleared 2021 · 95% similarity
510(k)
K203312 — Irrigated RF Catheter System
Abbott Medical · Cleared 2020 · 92% similarity
MAUDE
289 adverse events — RF catheter resistance failures
MAUDE · 2019–2024 · Class II devices
Guidance
Cardiac Ablation Catheters — FDA Guidance 2019
CDRH · Draft guidance · Still current
Recall
7 recalls — RF ablation catheter category
2018–2024 · Class II Class III recalls
How RA teams use Knowledge
Predicate research

Find cleared equivalents

Search the 510(k) database by device description. Get similarity scores, comparison tables, and clearance history.

Risk analysis

Surface failure modes

Pull MAUDE events for your device category. Map failure modes to your risk analysis — cited and traceable.

Guidance lookup

Find what FDA expects

Search guidance documents by device type or submission section. Get the exact passages relevant to your device.

Competitive intel

Map the landscape

See all cleared devices in your category, their predicates, applicants, and timelines. Know what you're walking into.

Sources indexed in Knowledge

We index what FDA reads. So you can cite what matters.

openFDA API
Device, drug, and food adverse events, recalls, registrations, and clearances via official FDA data.
510(k) Premarket Notifications
Full text and metadata for every 510(k) decision since 1976. Updated daily with new clearances.
MAUDE (MDR Reports)
15M+ manufacturer and user facility device experience reports. Failure mode classification built in.
FDA Guidance Documents
All current and draft guidance, with cross-references to device type, pathway, and applicable standards.
FDA Recall Database
Class I, II, and III device recalls — cause coded, device-type indexed, and linked to MAUDE reports.
Device Classification Database
1,700+ device categories with 21 CFR citations, product codes, special controls, and reclassification history.
TPLC (Total Product Life Cycle)
FDA's database linking 510(k)s, PMAs, and adverse events across a device's full product lifecycle.
EUDAMED
European database for EU MDR and IVDR compliance — UDI registration, notified body decisions, vigilance reports.
Consensus Standards
ISO 14971, IEC 62304, ISO 13485, ASTM standards library — mapped to device type and submission requirements.
Start researching

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