Openfda Device Tools#

Configuration File: openfda_device_tools.json Tool Type: Local Tools Count: 6

This page contains all tools defined in the openfda_device_tools.json configuration file.

Available Tools#

OpenFDADevice_get_classification (Type: OpenFDADeviceTool)#

Look up a medical device’s US regulatory classification by device name. Returns device class (1 =…

OpenFDADevice_get_classification tool specification

Tool Information:

  • Name: OpenFDADevice_get_classification

  • Type: OpenFDADeviceTool

  • Description: Look up a medical device’s US regulatory classification by device name. Returns device class (1 = general controls, 2 = special controls, 3 = premarket approval required), FDA product code, review panel, and CFR regulation number. Example: device_name=’pacemaker’ returns multiple pacemaker-related device types spanning Class 1 (test magnets) to Class 3 (implantable leads).

Parameters:

  • device_name (string) (required) Device type name, e.g. ‘pacemaker’, ‘insulin pump’.

  • limit ([‘integer’, ‘null’]) (optional) Max classifications to return, 1-100. Default 20.

Example Usage:

query = {
    "name": "OpenFDADevice_get_classification",
    "arguments": {
        "device_name": "example_value"
    }
}
result = tu.run(query)

OpenFDADevice_search_510k (Type: OpenFDADeviceTool)#

Search openFDA’s 510(k) premarket notification database by device name – the pathway most medica…

OpenFDADevice_search_510k tool specification

Tool Information:

  • Name: OpenFDADevice_search_510k

  • Type: OpenFDADeviceTool

  • Description: Search openFDA’s 510(k) premarket notification database by device name – the pathway most medical devices use to reach market by demonstrating substantial equivalence to an existing device. Returns each clearance’s K number, applicant, decision date and outcome, and clearance type. Example: device_name=’pacemaker’ returns clearances back to the 1980s-90s including K913805.

Parameters:

  • device_name (string) (required) Device name, e.g. ‘pacemaker’.

  • limit ([‘integer’, ‘null’]) (optional) Max clearances to return, 1-100. Default 20.

Example Usage:

query = {
    "name": "OpenFDADevice_search_510k",
    "arguments": {
        "device_name": "example_value"
    }
}
result = tu.run(query)

OpenFDADevice_search_adverse_events (Type: OpenFDADeviceTool)#

Search openFDA’s MAUDE database of medical device adverse event reports by device generic name. R…

OpenFDADevice_search_adverse_events tool specification

Tool Information:

  • Name: OpenFDADevice_search_adverse_events

  • Type: OpenFDADeviceTool

  • Description: Search openFDA’s MAUDE database of medical device adverse event reports by device generic name. Returns each report’s device brand/generic name and manufacturer, event type (Malfunction/Injury/Death), date, product problems, and patient problems. Example: device_name=’pacemaker’ surfaces reports like under-sensing and high capture threshold in pacemaker leads. ToolUniverse’s existing openFDA tools cover only drug adverse events (FAERS); this is the device side.

Parameters:

  • device_name (string) (required) Device generic name, e.g. ‘pacemaker’, ‘insulin pump’.

  • limit ([‘integer’, ‘null’]) (optional) Max reports to return, 1-100. Default 20.

Example Usage:

query = {
    "name": "OpenFDADevice_search_adverse_events",
    "arguments": {
        "device_name": "example_value"
    }
}
result = tu.run(query)

OpenFDADevice_search_pma (Type: OpenFDADeviceTool)#

Search openFDA’s Premarket Approval (PMA) database by trade name – the pathway required for high…

OpenFDADevice_search_pma tool specification

Tool Information:

  • Name: OpenFDADevice_search_pma

  • Type: OpenFDADeviceTool

  • Description: Search openFDA’s Premarket Approval (PMA) database by trade name – the pathway required for higher-risk (Class 3) devices, requiring clinical evidence of safety and effectiveness. Returns each application’s PMA number, applicant, trade name, decision date, and approval-order summary. Example: device_name=’pacemaker’ returns Guidant/Boston Scientific cardiac resynchronization therapy pacemaker approvals.

Parameters:

  • device_name (string) (required) Device trade name, e.g. ‘pacemaker’, ‘defibrillator’.

  • limit ([‘integer’, ‘null’]) (optional) Max PMA records to return, 1-100. Default 20.

Example Usage:

query = {
    "name": "OpenFDADevice_search_pma",
    "arguments": {
        "device_name": "example_value"
    }
}
result = tu.run(query)

OpenFDADevice_search_recalls (Type: OpenFDADeviceTool)#

Search openFDA’s medical device recall database by device name, recalling firm, or free text. Ret…

OpenFDADevice_search_recalls tool specification

Tool Information:

  • Name: OpenFDADevice_search_recalls

  • Type: OpenFDADeviceTool

  • Description: Search openFDA’s medical device recall database by device name, recalling firm, or free text. Returns each recall’s product description, recalling firm, stated reason and root cause, status, and date initiated. Example: query=’pacemaker’ returns hundreds of pacemaker-related recalls including terminated Guidant and Medtronic actions. ToolUniverse’s existing openFDA tools cover only drug data; this is the device side.

Parameters:

  • query (string) (required) Device name, recalling firm, or free text, e.g. ‘pacemaker’, ‘insulin pump’.

  • limit ([‘integer’, ‘null’]) (optional) Max recalls to return, 1-100. Default 20.

Example Usage:

query = {
    "name": "OpenFDADevice_search_recalls",
    "arguments": {
        "query": "example_value"
    }
}
result = tu.run(query)

OpenFDADevice_search_udi (Type: OpenFDADeviceTool)#

Search openFDA’s Unique Device Identifier (UDI) database by brand name, company, or free text. Re…

OpenFDADevice_search_udi tool specification

Tool Information:

  • Name: OpenFDADevice_search_udi

  • Type: OpenFDADeviceTool

  • Description: Search openFDA’s Unique Device Identifier (UDI) database by brand name, company, or free text. Returns each device’s brand name, company, description, primary device identifier (DI), GMDN terms, and regulatory device class. The UDI is the device-world equivalent of a drug’s NDC code. Example: query=’pacemaker’ returns real UDI records from Medtronic, Cardinal Health, and others.

Parameters:

  • query (string) (required) Brand name, company name, or free text, e.g. ‘pacemaker’.

  • limit ([‘integer’, ‘null’]) (optional) Max UDI records to return, 1-100. Default 20.

Example Usage:

query = {
    "name": "OpenFDADevice_search_udi",
    "arguments": {
        "query": "example_value"
    }
}
result = tu.run(query)