Knowledge

The right FDA data,
in seconds.

Complizen has direct access to every FDA clearance, recall, adverse event, guidance document, and decision letter. It finds the exact data your device needs — and puts it to work across everything else you do.

Device profileSingle-use RF ablation catheter15M+ FDA records scanned
510(k)
K211045 — Steerable Ablation Catheter
Biosense Webster · Cleared 2021 · 95% match
MAUDE
Tip detachment · 287 adverse events
2019–2024 · Class II ablation devices
Guidance
Cardiac Ablation Catheters — FDA 2019
CDRH · Still current · Premarket section
Recall
RF Catheter — Class II Recall
Q4 2023 · Cause: catheter shaft integrity
Ask anything

You ask. Complizen finds it for you.

Type a device, a product code, or a plain-English question — or let Complizen surface what’s relevant on its own. Either way, it pulls the exact records that matter, ranked for your device and ready to use. No sifting through anything.

  • Pulls from every source at once — and removes the duplicates
  • Ranks everything by relevance to your device — closest matches first
  • One click to cite — drop any record straight into your draft
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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CDRH · Draft guidance · Still current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

Complizen surfaces the closest cleared devices to yours, ranked by similarity, with comparison tables and clearance history ready to cite.

Risk analysis

Surface failure modes

Complizen pulls MAUDE events for your device category and maps failure modes straight into your risk analysis — cited and traceable.

Guidance lookup

Find what FDA expects

Complizen identifies the guidance documents that apply to your device and lifts the exact passages relevant to each submission section.

Competitive intel

Map the landscape

Complizen lays out every cleared device in your category — predicates, applicants, timelines — so you know what you're walking into.

One data core

The same data powers all of Complizen.

Knowledge isn’t a side tool you check now and then. The data it finds flows straight into the rest of the platform — every draft you write, every predicate you compare, every classification you run is built on the same FDA data. Find it once, and it’s already working everywhere.

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.
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