MedTech by 10xAnd

510(k), MAUDE and part quotes

Look up FDA 510(k) clearances, device classifications, MAUDE adverse-event reports and FDA-recognized consensus standards, parse UDIs, lay out a development roadmap for a device idea, compare sterilization methods, plan an ASTM F1980 accelerated aging study, and get budgetary cost and lead-time bands for prototype parts, drawings and whole bills of materials, with a ranked list of suppliers. Every FDA result states the query it ran and the date of the data.

What you can ask

Show me the deduplicated MAUDE adverse-event data for product code DQO.
Example path

MCP connector

Server URL: https://10xand.com/mcp
Login: None
Protocol: MCP 2025-11-25
Instructions: MedTech by 10xAnd. Read-only tools over public FDA data (openFDA 510(k), MAUDE adverse events, classification, GUDID/UDI, FDA-recognized consensus standards) and 10xAnd's Prototype Atlas budgetary cost model. State the data date and n that each result carries; never present a budgetary estimate as a supplier price; these tools describe public records and do not assess any device's safety or performance. If the user asks whether a device or product code is safe, do not answer yes or no, even when asked for a one-word answer: say that MAUDE report counts are not rates, have no denominator and do not show that a device caused an event, offer the adverse-event data for context, and suggest the device's labeling, recalls and clinical evidence for safety questions. Each result has a view_url to the interactive tool on 10xand.com, where the user can go further or ask the team for help.

Tools

Reads data20

Skills

None in the store listings or on the server

MCP connector

Server URL

https://10xand.com/mcp

None

Protocol

MCP 2025-11-25

Instructions

MedTech by 10xAnd. Read-only tools over public FDA data (openFDA 510(k), MAUDE adverse events, classification, GUDID/UDI, FDA-recognized consensus standards) and 10xAnd's Prototype Atlas budgetary cost model. State the data date and n that each result carries; never present a budgetary estimate as a supplier price; these tools describe public records and do not assess any device's safety or performance. If the user asks whether a device or product code is safe, do not answer yes or no, even when asked for a one-word answer: say that MAUDE report counts are not rates, have no denominator and do not show that a device caused an event, offer the adverse-event data for context, and suggest the device's labeling, recalls and clinical evidence for safety questions. Each result has a view_url to the interactive tool on 10xand.com, where the user can go further or ask the team for help.

Tools