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FDA Medical Devices Classification and Recalls

Provided By: John Snow Labs

FDA Medical Devices Classification and Recalls

Provided By: John Snow Labs

This data package contains the medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH), the complete list of recalls that were issued from 2015 to 2017, and descriptions of radiation-emitting products that have been recalled under an approved corrective action.

Product offers

The following offers are available for this product. Choose an offer to view the pricing and access duration options for the offer. Select an offer and continue to subscribe. Your subscription begins on the date that you accept the offer. Additional taxes or fees might apply.

Public offer

Payment schedule: Upfront payment | Offer auto-renewal: Supported
$0 for 12 months

Overview

Overview

This data package contains the lists of medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission, FDA medical devices recalls from 2015 to 2017 and  electronic products for which manufacturers are required to perform corrective actions when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product.


License Information

The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the Data Library on AWS. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.


Metadata

DescriptionValue
Data Package ComplexitySimple
Available EnrichmentsN/A
KeywordsRadiation-Emitting Recalls, FDA Recalls, Medical Devices Classification, Device Classification Panels, Product Code
Other TitlesFDA Medical Devices Recalls, FDA Medical Devices Classification and Corrective Actions

Included Datasets

  1. Medical Devices Classification

    The Medical Devices classification Database dataset contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission.

  2. Medical Devices Recalls

    The Food and Drug Administration Medical Devices Recalls dataset contains a complete list of recalls that were issued since 2015.

  3. Radiation-Emitting Electronic Products Corrective Actions

    Radiation-Emitting Electronic Products Corrective Actions provides descriptions of radiation-emitting products that have been recalled under an approved corrective action plan to remove defective and noncompliant products from the market.


Data Engineering Overview

We deliver high-quality data
  • Each dataset goes through 3 levels of quality review
    • 2 Manual reviews are done by domain experts
    • Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints
  • Data is normalized into one unified type system
    • All dates, unites, codes, currencies look the same
    • All null values are normalized to the same value
    • All dataset and field names are SQL and Hive compliant
  • Data and Metadata
    • Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters
    • Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated
  • Data Updates
    • Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted

Our data is curated and enriched by domain experts

Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:

  • Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
  • Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset
  • Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations
  • The data is always kept up to date – even when the source requires manual effort to get updates
  • Support for data subscribers is provided directly by the domain experts who curated the data sets
  • Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.

Need Help?


About Us

John Snow Labs , an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.

Provided By
Fulfillment Method
AWS Data Exchange

Data dictionaries

A data dictionary is a visual representation of the contents of a data set. The data represented here is for evaluation purposes only and may not accurately represent the actual content of the product.

Field name
Description
Example
Data type
Primary key
Nullable
Max length
Data set
Table name
Table description
Review_Panel

Review Panel

-
string
-
-
-
Medical Devices Classification
medical_devices_classification
Medical_Specialty

Medical specialty panel responsible for reviewing the product

-
string
-
-
-
Medical Devices Classification
medical_devices_classification
Product_Code

Product Code

-
string
-
false
-
Medical Devices Classification
medical_devices_classification
Device_Name

Device Category Name

-
string
-
false
-
Medical Devices Classification
medical_devices_classification
Device_Class
-
-
string
-
false
-
Medical Devices Classification
medical_devices_classification
Unclassified_Reason

Unclassified Reason Code

-
string
-
-
-
Medical Devices Classification
medical_devices_classification
Is_GMP_Exempt_Flag

GMP Exempt Flag

-
boolean
-
false
-
Medical Devices Classification
medical_devices_classification
Is_Third_Party_Flag

Third Party Review Eligible

-
boolean
-
-
-
Medical Devices Classification
medical_devices_classification
Regulation_Number

Regulation number of classification regulation which identifies this device

-
string
-
-
-
Medical Devices Classification
medical_devices_classification
Submission_Type_ID

Submission Type ID

-
numeric
-
-
-
Medical Devices Classification
medical_devices_classification

Data sets (3)

You will receive access to the following data sets

Revision access rules
All historical revisions | All future revisions
Name
Type
Data dictionary
AWS Region
Radiation-Emitting Electronic Products Corrective Actions
Included
US East (N. Virginia)
Medical Devices Recalls
Included
US East (N. Virginia)
Medical Devices Classification
Included
US East (N. Virginia)

Data dictionaries and samples

Sample data is for evaluation purposes only and may not accurately represent the actual content of the product.

Name
Resource
File type
File size
Description
Medical Devices Classification
Data set
-
-
-
Data dictionary
Data dictionary
text/csv
-
Medical Devices Recalls
Data set
-
-
-
Radiation-Emitting Electronic Products Corrective Actions
Data set
-
-
-

Usage information

By subscribing to this product, you agree that your use of this product is subject to the provider's offer terms including pricing information and Data Subscription Agreement . Your use of AWS services remains subject to the AWS Customer Agreement  or other agreement with AWS governing your use of such services.

Support information

Support contact email address
Refund policy
No refunds offered. For any questions email us at info@johnsnowlabs.com
General AWS Data Exchange support