Who it is for
Regulatory affairs, quality, or market research staff at a medical device company.
AI Connectors · Healthcare & Life Sciences
FDA medical device regulatory and safety records
Overview
NyquistAI queries a database of United States medical device regulation. The record lists 510(k), PMA, De Novo, and HDE submissions along with their clearances and approvals, plus adverse event reports, recalls, and agency guidance.
The stated uses are research, compliance work, and ongoing monitoring of a device area or a competitor's filings. The example prompt asks about recent behavioral clinical trials on weight loss, which suggests search across the corpus rather than lookup of one known record.
A disclaimer is included in the listing itself. The app supplies regulatory and safety information, and it does not offer medical advice or clinical recommendations.
Regulatory affairs, quality, or market research staff at a medical device company.
Several FDA pathway types sit in one place, with adverse events and recalls alongside the clearance records.
Availability
NyquistAI is listed in the ChatGPT apps directory only. Nyquist Data. Inc. has no connector under the same domain in the Claude directory; 392 of the 3,150 products here are on both marketplaces, and this is not one of them.
ChatGPT apps are built on MCP, and the same server can back a Claude connector, so the absence is a distribution decision rather than a technical one.
ChatGPT listing
Same company
FDA medical device clearances, recalls and adverse events
Claude
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This is an independent catalogue entry compiled by Node8 from NyquistAI's public marketplace listing as it stood in August 2026. Listing facts come from the marketplaces; the comparisons against the rest of the directory and any live-endpoint measurements are Node8's. Node8 is not affiliated with Nyquist Data. Inc., and inclusion here is not an endorsement.
Node8 builds MCP servers end to end: deciding which tools are worth exposing, the authentication and permission model, the review submissions, and the onboarding that gets them used. One server serves ChatGPT, Claude, and Microsoft Copilot.