FDA Device Dataset

# FDA Device Dataset

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The FDA Device Dataset includes all data related to FDA regulated devices, collected since tracking began, under the FDA's device category. Device events tracked in the dataset:

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- 510(k) Clearance
- Device Classification
- Recall Enforcement Reports
- Adverse Events
- Pre-market Approval
- Device Recalls
- Registrations and Listings
- COVID-19 Serological Testing Evaluations
- Unique Device Identifiers (UDI)

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A table per each of the device event is included in the dataset and each updates daily with any changes released by the FDA.

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You can leverage this dataset to track pre-market FDA device approvals, detect device recalls and identify the firms or companies associated with them, and query the results of device serology tests (which detect the body’s immune response to COVID-19), among many other applications.

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The device data dates back to 1976 and is flattened making it easily queryable and quick to integrate with existing data. The largest table in the dataset is adverse events which currently includes 92M records. ***The trial includes 4000 rows from each of the device tables. Any new device events that are tracked by the FDA will be added to the FDA Device Dataset going forward.

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✨ Features

- Comprehensive dataset on FDA-approved medical devices.
- Includes details on device classification, approval history, and regulatory status.
- Provides insights into manufacturing data and device recall history.
- Updated regularly to reflect the latest FDA data.

<br/>Reach out to [e-mail] if you have any questions regarding the FDA Device Dataset.

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原始信息汇总

数据集详情

数据集名称

FDA Device Dataset

数据集描述

该数据集包含与FDA（美国食品药品监督管理局）设备相关的信息。

数据集来源

数据集来源于Dataplex Consulting & Data Products。

数据集内容

数据集内容涉及FDA设备的相关数据，具体细节未详细说明。

数据集使用

数据集的使用方法和具体应用场景未详细说明。

数据集格式

数据集的格式和结构未详细说明。

数据集更新

数据集的更新频率和最新更新时间未详细说明。

数据集版权

数据集的版权和使用许可未详细说明。

搜集汇总

背景与挑战

背景概述

该数据集涵盖FDA自1976年起监管的所有医疗设备数据，包含510(k)审批、设备分类等9类事件记录，每日更新且采用扁平化结构便于查询。特别包含9200万条不良事件记录，可用于追踪设备审批、召回监测及COVID-19血清检测结果分析。