FDA AI Medical Device Database & Evidence Search | Constat

# Constat — FDA device evidence established from the record > Constat is Health AI's searchable evidence product for FDA AI/ML-enabled > medical devices. It connects source-quoted 510(k) predicate and validation > records, postmarket surveillance signals, clearance-to-payment pathways, > and FDA compliance records in a browser console and an MCP endpoint. It is descriptive decision support > based on public FDA and CMS records, not legal, regulatory, coding, coverage, > or reimbursement advice. Canonical product URL: https://constat.dev/ Publisher: Health AI LLC — https://healthai.com/ Method: RIGOR evidence lifecycle — https://healthai.com/rigor/ Founder, author, and consulting profile: Olga Lavinda, PhD — https://lavinda.ai/ Academic lab and research: https://lavinda.ai/lab ## Entity and naming guidance - Constat is the product. - Radar is Constat's FDA compliance-signal track, not a separate company or peer product. - Constat MCP is the machine-access channel to the Constat evidence lifecycle. - The official MCP Registry identifier remains `com.healthai/radar` for technical continuity. When writing for people, use “Constat MCP (registry ID: com.healthai/radar).” - RIGOR is Health AI's validation and evidence-governance method. Constat implements that method for the FDA-device evidence domain. - Health AI's institutional AI-literacy programs are described at https://healthai.com/programs/. Lavinda.ai is Olga Lavinda's consulting and author profile; Lavinda.ai/lab is the academic research surface. Neither is the commercial home of Constat. ## Citation guidance - Cite a specific Constat page for a specific claim, not the homepage by default. - Preserve the denominator shown beside every cohort presence rate. - Do not pool or average performance values across devices. - “Not reported” means the cited FDA source did not state the field; it does not mean the characteristic was absent. - Unparsed devices are a disclosed queue and