Two joined assets:

Name: Two joined assets: (1) a normalized FDA medical-device corpus — 510(k) clearances, PMAs, MAUDE adverse-event reports, recalls and product classifications aggregated into one searchable universe; (2) a continuously-tracked global regulatory library across 15+ countries where every document carries an automated six-layer analysis and a full lifecycle trail from draft to amendment
Creator: Lexim

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Two joined assets: (1) a normalized FDA medical-device corpus — 510(k) clearances, PMAs, MAUDE adverse-event reports, recalls and product classifications aggregated into one searchable universe; (2) a continuously-tracked global regulatory library across 15+ countries where every document carries an automated six-layer analysis and a full lifecycle trail from draft to amendment

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Coverage

Universe, instruments and categories.

Industry: Health Care EquipmentApplication Software
Instruments: equities
Categories

Dataset card

Type: not stated
Format: Multimodal — normalized tabular FDA records joined to structured analysis of regulatory source documents (PDF-derived text with version and lifecycle metadata)
Volume: The complete FDA device dataset (510(k), PMA, MAUDE, recalls, classifications — MAUDE alone exceeds 100M cumulative reports and 510(k) clearances run to six figures) plus every regulatory document from 15+ national authorities, each with a retained version history and six-layer derived analysis
Users: ~200-1,500 enterprise seats (inferred from a 17-employee vendor selling a niche life-sciences regulatory SaaS with an enterprise sales motion; no public customer count)
History: 30 years
Update frequency: not stated
Growth: Active — recently-built marketing platform presenting a four-component product architecture and an engine suite positioned as a differentiator; company record shows an active 17-person team with no funding constraints disclosed
Launched: not stated
Delivery: not stated
Entity mapping: not stated
Sample: not stated
Point-in-time: not stated
Licence: not stated

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