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Dataplex: FDA Medical Device Data | 24M+ Rows of Healthcare Device Data for Research & Analysis

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ID
FEED_ID
FILE_FEED_ID
DEVICE_NAME
APPLICANT
K_NUMBER
DATE_RECEIVED
EXPEDITED_REVIEW_FLAG
OPENFDA_MEDICAL_SPECIALTY_DESCRIPTION
OPENFDA_DEVICE_CLASS
OPENFDA_FEI_NUMBER
OPENFDA_REGISTRATION_NUMBER
DECISION_DESCRIPTION
STATEMENT_OR_SUMMARY
ADVISORY_COMMITTEE
DECISION_DATE
REVIEW_ADVISORY_COMMITTEE
DECISION_CODE
CONTACT
OPENFDA_REGULATION_NUMBER
PRODUCT_CODE
THIRD_PARTY_FLAG
CLEARANCE_TYPE
ADVISORY_COMMITTEE_DESCRIPTION
ADDRESS_1
ADDRESS_2
CITY
STATE
ZIP_CODE
POSTAL_CODE
COUNTRY_CODE
CREATED_AT
UPDATED_AT
1 xxxxxxxxxx Xxxxxxxxx xxxxxx xxxxxxxxxx Xxxxx Xxxxxx Xxxxxxxxxx Xxxxxx Xxxxxxxxx Xxxxxxxxxx xxxxxxxxx Xxxxxxxxx xxxxxxxxx Xxxxxxx xxxxxx Xxxxx xxxxxxxxxx xxxxxx Xxxxxxxxxx xxxxxx Xxxxx Xxxxxx xxxxx xxxxxxxx xxxxxxx Xxxxx Xxxxxxxx xxxxxxxxxx xxxxxx Xxxxxxxxx xxxxxx Xxxxxxxxx Xxxxxxxxx
2 xxxxxxxxxx Xxxxxx Xxxxx xxxxxx xxxxxxx xxxxxxx Xxxxx xxxxxx Xxxxxxxxxx xxxxxxxx xxxxxx Xxxxx Xxxxxxx xxxxxx Xxxxxxxx Xxxxxxx Xxxxx xxxxxx xxxxxxxxxx Xxxxx xxxxxxxxxx xxxxxxxxx Xxxxxxx xxxxxxxx xxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxxxx xxxxxxxxx Xxxxxxxxxx Xxxxxx Xxxxxxxxx xxxxx
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... Xxxxxxxx xxxxxxxxxx Xxxxxx Xxxxxxxxx Xxxxxxxxxx xxxxxxx Xxxxxxxxxx Xxxxxxxxx Xxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx Xxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx Xxxxx xxxxxxxx xxxxxx Xxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx Xxxxxxx Xxxxxxxxx xxxxxx Xxxxx Xxxxx Xxxxxx Xxxxxxxxx Xxxxxxxxx xxxxx Xxxxx
Sign In To Preview Data
#
ID
FEED_ID
FILE_FEED_ID
DATE_REPORT
DATE_OF_EVENT
INITIAL_REPORT_TO_FDA
DEVICE_DATE_OF_MANUFACTURER
DATE_CHANGED
DATE_ADDED
EXEMPTION_NUMBER
DATE_RECEIVED
EVENT_TYPE
DEVICE
MANUFACTURER_ADDRESS_1
MANUFACTURER_ADDRESS_2
MANUFACTURER_CITY
MANUFACTURER_COUNTRY
MANUFACTURER_NAME
MANUFACTURER_POSTAL_CODE
MANUFACTURER_STATE
MANUFACTURER_ZIP_CODE_EXT
MANUFACTURER_ZIP_CODE
MANUFACTURER_CONTACT_ADDRESS_1
MANUFACTURER_CONTACT_ADDRESS_2
MANUFACTURER_CONTACT_AREA_CODE
MANUFACTURER_CONTACT_CITY
MANUFACTURER_CONTACT_COUNTRY
MANUFACTURER_CONTACT_EXCHANGE
MANUFACTURER_CONTACT_EXTENSION
MANUFACTURER_CONTACT_F_NAME
MANUFACTURER_CONTACT_L_NAME
MANUFACTURER_CONTACT_PCITY
MANUFACTURER_CONTACT_PCOUNTRY
MANUFACTURER_CONTACT_PHONE_NUMBER
MANUFACTURER_CONTACT_PLOCAL
MANUFACTURER_CONTACT_POSTAL_CODE
MANUFACTURER_CONTACT_STATE
MANUFACTURER_CONTACT_T_NAME
MANUFACTURER_CONTACT_ZIP_CODE
MANUFACTURER_CONTACT_ZIP_EXT
MANUFACTURER_G1_ADDRESS_1
MANUFACTURER_G1_ADDRESS_2
MANUFACTURER_G1_CITY
MANUFACTURER_G1_COUNTRY
MANUFACTURER_G1_NAME
MANUFACTURER_G1_POSTAL_CODE
MANUFACTURER_G1_STATE
MANUFACTURER_G1_ZIP_CODE_EXT
MANUFACTURER_G1_ZIP_CODE
MANUFACTURER_LINK_FLAG
DATE_MANUFACTURER_RECEIVED
DISTRIBUTOR_NAME
DISTRIBUTOR_ADDRESS_1
DISTRIBUTOR_ADDRESS_2
DISTRIBUTOR_CITY
DISTRIBUTOR_STATE
DISTRIBUTOR_ZIP_CODE
DISTRIBUTOR_ZIP_CODE_EXT
SUMMARY_REPORT_FLAG
REPORT_NUMBER
SOURCE_TYPE
HEALTH_PROFESSIONAL
PATIENT
ADVERSE_EVENT_FLAG
REPORT_SOURCE_CODE
SUPPL_DATES_MFR_RECEIVED
PMA_PMN_NUMBER
NUMBER_PATIENTS_IN_EVENT
EVENT_LOCATION
REPORT_TO_MANUFACTURER
NOE_SUMMARIZED
MDR_REPORT_KEY
PREVIOUS_USE_CODE
MDR_TEXT
NUMBER_DEVICES_IN_EVENT
PRODUCT_PROBLEMS
REPORT_TO_FDA
PRODUCT_PROBLEM_FLAG
TYPE_OF_REPORT
REPORTER_COUNTRY_CODE
REPORTER_OCCUPATION_CODE
DATE_REPORT_TO_FDA
DATE_REPORT_TO_MANUFACTURER
SINGLE_USE_FLAG
REMOVAL_CORRECTION_NUMBER
SUPPL_DATES_FDA_RECEIVED
REPROCESSED_AND_REUSED_FLAG
EVENT_KEY
REMEDIAL_ACTION
DATE_FACILITY_AWARE
CREATED_AT
UPDATED_AT
1 xxxxxxxxxx Xxxxxxxxx xxxxxx xxxxxxxxxx Xxxxx Xxxxxx Xxxxxxxxxx Xxxxxx Xxxxxxxxx Xxxxxxxxxx xxxxxxxxx Xxxxxxxxx xxxxxxxxx Xxxxxxx xxxxxx Xxxxx xxxxxxxxxx xxxxxx Xxxxxxxxxx xxxxxx Xxxxx Xxxxxx xxxxx xxxxxxxx xxxxxxx Xxxxx Xxxxxxxx xxxxxxxxxx xxxxxx Xxxxxxxxx xxxxxx Xxxxxxxxx Xxxxxxxxx xxxxxxxxxx Xxxxxx Xxxxx xxxxxx xxxxxxx xxxxxxx Xxxxx xxxxxx Xxxxxxxxxx xxxxxxxx xxxxxx Xxxxx Xxxxxxx xxxxxx Xxxxxxxx Xxxxxxx Xxxxx xxxxxx xxxxxxxxxx Xxxxx xxxxxxxxxx xxxxxxxxx Xxxxxxx xxxxxxxx xxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxxxx xxxxxxxxx Xxxxxxxxxx Xxxxxx Xxxxxxxxx xxxxx xxxxxxx xxxxxxxxx Xxxxxx Xxxxxxx Xxxxxxxxx xxxxxxxxx xxxxxxxxx Xxxxx xxxxxxxx Xxxxxxx xxxxxxxxx Xxxxxxx xxxxx Xxxxxxx xxxxxxx Xxxxx xxxxxxxxxx Xxxxxxx Xxxxx xxxxxxxxxx Xxxxxx xxxxxx Xxxxxxxxx xxxxx Xxxxxxxxxx xxxxxx
2 xxxxx xxxxxxxx Xxxxxx Xxxxxxxxxx xxxxxxxxx Xxxxxxxxxx xxxxxxxx xxxxx Xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxx xxxxxx Xxxxxxxxxx xxxxxxxxxx Xxxxx xxxxxxx Xxxxxxxx Xxxxxxx xxxxx xxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxxxx Xxxxx xxxxx xxxxxxxxx xxxxxxx Xxxxxxxxx Xxxxxxx xxxxxxxxxx Xxxxx xxxxxxxxx xxxxxxx Xxxxxx xxxxxxxxx xxxxx Xxxxxxx xxxxxxxxx Xxxxxxxx xxxxxxxx Xxxxxxxx Xxxxxxxx xxxxxxxx xxxxxxxxx Xxxxxxx Xxxxxxxxx xxxxxxxx xxxxx Xxxxxxxxxx xxxxxxxxxx xxxxxx Xxxxx Xxxxxxx Xxxxx Xxxxxx Xxxxx Xxxxxxxxx xxxxxx xxxxxxxx Xxxxxxxxx Xxxxxx Xxxxxxxxxx Xxxxxx Xxxxx Xxxxxxx xxxxxxxxx Xxxxx xxxxx Xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxx xxxxxxxxx Xxxxx Xxxxx Xxxxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx Xxxxxxx Xxxxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxxxxx xxxxx Xxxxxxx xxxxxxxxxx
3 Xxxxxxxxx Xxxxxxxx xxxxxxxxxx xxxxxxx Xxxxxxxx xxxxx Xxxxxx xxxxxx xxxxxxxx xxxxxxx Xxxxx Xxxxxxxxx Xxxxx Xxxxxxx Xxxxxxxx xxxxxxxxx xxxxxxxx xxxxx Xxxxxxxxxx Xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxxx xxxxx Xxxxxxxxxx Xxxxxxxxx xxxxxxx Xxxxxx Xxxxx Xxxxxxxx xxxxxxxxx xxxxxxxx Xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx Xxxxx xxxxxxx xxxxxxxxxx Xxxxxx Xxxxxxxxx xxxxxxx Xxxxxxxx xxxxx xxxxx Xxxxxxxxxx Xxxxxxx Xxxxxxxx Xxxxxxx xxxxx xxxxxxx Xxxxx xxxxxxxxxx Xxxxxxxxxx xxxxxxx Xxxxx xxxxxxxxx xxxxxxxx Xxxxxxxx xxxxxxxx Xxxxxxx Xxxxxx Xxxxxxxxx Xxxxxxxx Xxxxxxxxxx Xxxxxxx Xxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxxxxxxx Xxxxxxx Xxxxx Xxxxx Xxxxx Xxxxxxx xxxxx xxxxxxxxx xxxxxxx Xxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxx Xxxxx xxxxxxx Xxxxxx Xxxxx xxxxxxxxxx xxxxxxxxx Xxxxxxxxxx
4 Xxxxxxxxx Xxxxxxxx xxxxxxxxx Xxxxxxx Xxxxxxx Xxxxx xxxxxxxxxx Xxxxxxxxx Xxxxxxx Xxxxxxx xxxxxxxx xxxxx Xxxxx Xxxxxxxx xxxxxxxx Xxxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx Xxxxxxx Xxxxxxx Xxxxxxx Xxxxxxx xxxxxxx Xxxxxxxxxx xxxxxxxx Xxxxx xxxxxxxxxx xxxxxxxxxx xxxxxx xxxxxxxx Xxxxxxxx xxxxxx xxxxxxxx xxxxxx Xxxxxxxx xxxxxxxxx xxxxx Xxxxxxxxxx Xxxxxxxxx Xxxxxxx xxxxxxxx Xxxxxxx Xxxxxxxxxx Xxxxxxxxx xxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxx xxxxx Xxxxx Xxxxxxxx xxxxxxxxxx Xxxxxx Xxxxxxxxx Xxxxxxxxxx xxxxxxx Xxxxxxxxxx Xxxxxxxxx Xxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx Xxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx Xxxxx xxxxxxxx xxxxxx Xxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx Xxxxxxx Xxxxxxxxx xxxxxx Xxxxx Xxxxx Xxxxxx Xxxxxxxxx Xxxxxxxxx xxxxx Xxxxx Xxxxxxxxxx Xxxxxxx Xxxxxxxxxx Xxxxxxxx xxxxxxx
5 xxxxxxxx Xxxxxx Xxxxxxxxx Xxxxxxxxxx Xxxxxx Xxxxxx Xxxxxxx xxxxxxxxxx Xxxxxxx Xxxxxxxxxx xxxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxx xxxxxxx Xxxxxxxx Xxxxxxxx Xxxxxxx xxxxxx xxxxx xxxxx Xxxxxxxxx xxxxx Xxxxx Xxxxxx xxxxxxxxxx Xxxxxxxx Xxxxxxxx Xxxxxxxxx Xxxxxxxxxx xxxxxx Xxxxx Xxxxxxxx xxxxxx Xxxxx Xxxxxx xxxxxx xxxxxxxx Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx Xxxxx Xxxxxxx Xxxxxxx Xxxxxx Xxxxxx xxxxxxxx Xxxxxxxxx Xxxxx Xxxxxxx xxxxxxxxx Xxxxxxxxx xxxxxxx Xxxxxxxx Xxxxxxxxxx xxxxxx xxxxxxxxxx xxxxxx xxxxxx Xxxxxxxxxx xxxxxxx Xxxxxxxxxx xxxxx Xxxxxxxxx Xxxxxxx Xxxxxxxxx Xxxxx Xxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxx xxxxxxxxxx xxxxxxx xxxxxxxx Xxxxx xxxxx xxxxxx Xxxxxx xxxxxxxxxx xxxxxxxxxx Xxxxxxxxx xxxxxxx Xxxxxxx
6 Xxxxxxxxxx Xxxxxxxx xxxxxx xxxxxx Xxxxxx xxxxxx xxxxx Xxxxxxxxx Xxxxxxxxx Xxxxxx Xxxxx Xxxxxxxxx Xxxxxx Xxxxxx xxxxxx xxxxx xxxxxxx xxxxxxxxxx xxxxxx Xxxxxxx Xxxxx xxxxxxxxxx Xxxxx xxxxxxx xxxxxxx Xxxxxxxxxx Xxxxx xxxxxxx Xxxxxxxx Xxxxxx xxxxxxxxxx Xxxxx Xxxxxxx xxxxx xxxxxx xxxxxx Xxxxxxxx xxxxxxx Xxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxx Xxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxxx Xxxxx Xxxxxx Xxxxxx xxxxxx Xxxxxxxx Xxxxx xxxxx Xxxxxxxxxx xxxxxx xxxxx xxxxxxx xxxxx Xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxx xxxxxxxxxx Xxxxxxxxxx Xxxxxx xxxxxx Xxxxxxxxxx Xxxxxx Xxxxxx Xxxxxxx Xxxxxx xxxxxxxx xxxxx Xxxxxxxxxx Xxxxx xxxxxxx xxxxxxxx xxxxxxxx Xxxxxxxx xxxxxxx xxxxxx Xxxxxxxx xxxxxxx Xxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxx Xxxxxxxx xxxxx
7 Xxxxx Xxxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxx Xxxxxxxx Xxxxx Xxxxxxxx Xxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxxxx Xxxxxx Xxxxxxxxxx Xxxxxx xxxxxxxx xxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx Xxxxxx Xxxxxx Xxxxxxxxxx xxxxxxxxxx Xxxxxxxxx xxxxxxxx xxxxxxx xxxxx Xxxxxxx xxxxxxxxx Xxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxx Xxxxx xxxxx xxxxxxx xxxxxxxx xxxxxx xxxxxxx Xxxxx Xxxxxxxxx Xxxxxxx Xxxxxxx Xxxxxxxx xxxxxxx xxxxxxxxx Xxxxxxxx xxxxxxxxx xxxxxxx xxxxxx Xxxxxxxxxx Xxxxxx Xxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx Xxxxxxxxxx xxxxxxxxx xxxxxxxxx Xxxxxx Xxxxxxx Xxxxxxxx xxxxxxx xxxxxxx Xxxxxxxx xxxxxxx Xxxxxxx Xxxxxxx Xxxxxxxxx Xxxxx xxxxx Xxxxxxx xxxxxxxxx Xxxxx Xxxxxxxx xxxxxxxxx Xxxxxx xxxxxxxx Xxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxx xxxxxxxxx xxxxx xxxxxx Xxxxxxxxx xxxxxxxxx xxxxxx
8 xxxxxxxxx Xxxxxxxx Xxxxxxxxxx Xxxxx Xxxxxxxx xxxxxxxx Xxxxxxxxx Xxxxxxxxx Xxxxxxxx Xxxxxxxxx Xxxxxxx Xxxxxx Xxxxxxxx xxxxxxx Xxxxxx Xxxxxx xxxxxxx Xxxxxxx Xxxxx Xxxxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxxx Xxxxxxxxx xxxxxxx xxxxxxxxxx Xxxxx xxxxxxxxx Xxxxxxx xxxxxxxx Xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxx Xxxxxxx Xxxxxxxx Xxxxxx Xxxxx Xxxxxxxxx Xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxx xxxxxxx Xxxxxxxx Xxxxxxx xxxxx Xxxxxx xxxxxxxx xxxxxx xxxxxxx Xxxxxxxxxx Xxxxxxxxx xxxxxxxx Xxxxxxx Xxxxxxxxxx Xxxxxx Xxxxxxxx xxxxxxxxx xxxxxxxx Xxxxxxxxxx Xxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxx Xxxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxx Xxxxxxxx xxxxxxx xxxxxxxxx xxxxxx Xxxxx Xxxxxx Xxxxxxxxxx xxxxx xxxxxxxx xxxxxxxx Xxxxx xxxxxxx xxxxxxx xxxxxxx xxxxxxxxxx xxxxx Xxxxxxx xxxxx
9 Xxxxxxxxx xxxxx Xxxxxxx xxxxxxxx Xxxxx Xxxxxxxxx Xxxxx xxxxxxx Xxxxxxx xxxxxxx xxxxx Xxxxxxxxx Xxxxxxx Xxxxxx Xxxxxx xxxxx xxxxxxxx Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxx Xxxxxxxx xxxxx Xxxxxxxx xxxxxx xxxxxxxxxx xxxxx xxxxxx xxxxxx Xxxxx Xxxxxx xxxxxxxxx Xxxxxxxxx Xxxxxx xxxxxxxx xxxxxxxx xxxxxxx xxxxxxxxx Xxxxxxxx Xxxxxxxxxx Xxxxxxx Xxxxxxxxx xxxxxxx xxxxxx Xxxxx xxxxx Xxxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxx Xxxxxxx xxxxx xxxxxx xxxxxx xxxxxxx Xxxxxx xxxxxx Xxxxxxxx Xxxxxxx xxxxxxx Xxxxxxx Xxxxxxxx xxxxxxxx Xxxxxxxxx xxxxxxxxxx Xxxxxxxxx Xxxxxxxxxx Xxxxxxxxxx xxxxx Xxxxxx Xxxxxxxx Xxxxxxx xxxxxxxxxx Xxxxxxxxx xxxxxxxxx Xxxxxxxx Xxxxxxxx Xxxxx Xxxxxx Xxxxxxxxx xxxxx xxxxxxxxxx Xxxxxxx xxxxxxx Xxxxx xxxxxxxx Xxxxxx xxxxx Xxxxxxx Xxxxxx Xxxxxxxxx
10 Xxxxx Xxxxxxx xxxxxx xxxxxx xxxxxxxxx xxxxx Xxxxxxx Xxxxxxxx xxxxx Xxxxxxxxx Xxxxxxxxx Xxxxxxxxx Xxxxxxxx xxxxxxxxx xxxxxxxxx Xxxxx xxxxxxxx Xxxxxx xxxxxx Xxxxxxxx Xxxxxxxxx Xxxxxxxx xxxxxxxx Xxxxx xxxxx Xxxxxxxxx xxxxx Xxxxxxxx Xxxxxx Xxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxxxxxxx Xxxxxxxx Xxxxxxxxxx Xxxxxxxx xxxxxxxxxx Xxxxx xxxxxxxxx Xxxxxxxxxx Xxxxxxx Xxxxxxxxx Xxxxx xxxxxxxxx Xxxxx Xxxxx xxxxx xxxxxx xxxxxx xxxxxxx xxxxxx Xxxxx xxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxx xxxxxxxx xxxxx xxxxxxxx xxxxx Xxxxx xxxxxx xxxxxxxxx Xxxxxxxx Xxxxxxxxx Xxxxx Xxxxx xxxxxxxx Xxxxx xxxxxxxxxx Xxxxxxx xxxxxxx xxxxxx xxxxxx xxxxxxxxx Xxxxxx Xxxxx xxxxxxxxxx Xxxxxxxxxx xxxxx Xxxxx Xxxxxxx Xxxxx xxxxxxxxx xxxxxxxxx Xxxxxxx xxxxxxx xxxxx
... xxxxxxx xxxxxxxx Xxxxxxx xxxxxxxx Xxxxxxxxxx Xxxxxxx xxxxxxx xxxxxx Xxxxxxxxxx Xxxxx xxxxxxx Xxxxxxxx Xxxxxxxxxx Xxxxx Xxxxxx xxxxx xxxxx Xxxxxxxx Xxxxxx Xxxxx Xxxxx xxxxx Xxxxxxx Xxxxxxxxx xxxxxx Xxxxxxxxxx Xxxxxxxxx xxxxx Xxxxxxxx xxxxxxxxxx Xxxxxxx Xxxxxxxx Xxxxxx Xxxxxxxxxx xxxxxx xxxxxxxxx Xxxxxx xxxxxxxxx Xxxxxxxxx Xxxxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxxxxx Xxxxxx Xxxxxxxx Xxxxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxx xxxxx Xxxxxxxxxx Xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx Xxxxxxxxxx Xxxxxx Xxxxxxx Xxxxxxxxx xxxxxxxxx xxxxxx Xxxxx xxxxxxxxxx xxxxxx xxxxx xxxxxxxxx xxxxxxxx Xxxxxxx Xxxxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx Xxxxxxxx xxxxxxxx xxxxxxxx Xxxxxxxx xxxxxxxxxx xxxxxxxx Xxxxxx xxxxxxxxx Xxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxx Xxxxx xxxxxxx Xxxxxxx Xxxxxxx Xxxxxxxxxx xxxxxxxxx
Sign In To Preview Data
Volume
600
+ attributes
Data Quality
100%
attributes consistent data types
Avail. Format
.csv
File
Coverage
1
Country
History
48
years

Data Dictionary

[Sample] DEVICE_510K_CLEARANCES_v2.csv
Attribute Type Example Mapping
ID
String 40132f2d-fd84-5863-a257-b86942943ed1
FEED_ID
String 1a3b7bba38843e7d05c8d1b69dc4c969
FILE_FEED_ID
String 95cb90e1-f4ec-4f11-9780-f6db507268c9
DEVICE_NAME
String TUOHY EPIDURAL NEEDLES
APPLICANT
String HAKKO SHOJI CO., LTD.
K_NUMBER
String K961152
DATE_RECEIVED
DateTime 1996-03-22T00:00:00+00:00
EXPEDITED_REVIEW_FLAG
OPENFDA_MEDICAL_SPECIALTY_DESCRIPTION
String Anesthesiology
OPENFDA_DEVICE_CLASS
Integer 2
OPENFDA_FEI_NUMBER
String """["3005146313","3019729537","3000204727","3013162291","...
OPENFDA_REGISTRATION_NUMBER
String """["3005146313","3019729537","3013162291","2011171","122...
DECISION_DESCRIPTION
String Substantially Equivalent
STATEMENT_OR_SUMMARY
String Statement
ADVISORY_COMMITTEE
String AN
DECISION_DATE
DateTime 1997-03-19T00:00:00+00:00
REVIEW_ADVISORY_COMMITTEE
String AN
DECISION_CODE
String SESE
CONTACT
String JOHN ROGERS
OPENFDA_REGULATION_NUMBER
Float 868.515
PRODUCT_CODE
String BSP
THIRD_PARTY_FLAG
Boolean f
CLEARANCE_TYPE
String Traditional
ADVISORY_COMMITTEE_DESCRIPTION
String Anesthesiology
ADDRESS_1
String 3726 LONSDALE AVE.
ADDRESS_2
CITY
String CINCINNATI
STATE
String OH
ZIP_CODE
Integer 45227
POSTAL_CODE
Integer 45227
COUNTRY_CODE
String US
CREATED_AT
String 2024-09-29 12:10:30.972 -0700
UPDATED_AT
String 2024-09-29 12:10:30.972 -0700
[Sample] DEVICE_ADVERSE_EVENTS_v2.csv
Attribute Type Example Mapping
ID
String 201e77eb-b6a0-5bd1-8a64-c3ff1bd62975
FEED_ID
String 6e64d273d057cf204e7e31af2e82bcda
FILE_FEED_ID
String 2d080299-ed5c-422d-9cd1-df0adbee1ae6
DATE_REPORT
DateTime 2024-06-24T00:00:00+00:00
DATE_OF_EVENT
DateTime 2024-01-20T00:00:00+00:00
INITIAL_REPORT_TO_FDA
Boolean f
DEVICE_DATE_OF_MANUFACTURER
DateTime 2021-05-18T00:00:00+00:00
DATE_CHANGED
DateTime 2024-06-28T00:00:00+00:00
DATE_ADDED
DateTime 2024-06-24T00:00:00+00:00
EXEMPTION_NUMBER
DATE_RECEIVED
DateTime 2024-06-24T00:00:00+00:00
EVENT_TYPE
String Injury
DEVICE
String [ { "brand_name": "GM HELIX IMPLANT,TI,4.0X13", ...
MANUFACTURER_ADDRESS_1
MANUFACTURER_ADDRESS_2
MANUFACTURER_CITY
MANUFACTURER_COUNTRY
MANUFACTURER_NAME
MANUFACTURER_POSTAL_CODE
MANUFACTURER_STATE
MANUFACTURER_ZIP_CODE_EXT
MANUFACTURER_ZIP_CODE
MANUFACTURER_CONTACT_ADDRESS_1
String 60 MINUTEMAN ROAD
MANUFACTURER_CONTACT_ADDRESS_2
MANUFACTURER_CONTACT_AREA_CODE
Integer 978
MANUFACTURER_CONTACT_CITY
String ANDOVER
MANUFACTURER_CONTACT_COUNTRY
String US
MANUFACTURER_CONTACT_EXCHANGE
Integer 978
MANUFACTURER_CONTACT_EXTENSION
MANUFACTURER_CONTACT_F_NAME
String JENNIFER
MANUFACTURER_CONTACT_L_NAME
String JACKSON
MANUFACTURER_CONTACT_PCITY
Integer 97874725
MANUFACTURER_CONTACT_PCOUNTRY
MANUFACTURER_CONTACT_PHONE_NUMBER
Integer 9787
MANUFACTURER_CONTACT_PLOCAL
Integer 9787472509
MANUFACTURER_CONTACT_POSTAL_CODE
Float 1810.0
MANUFACTURER_CONTACT_STATE
String MA
MANUFACTURER_CONTACT_T_NAME
String MRS
MANUFACTURER_CONTACT_ZIP_CODE
Float 1810.0
MANUFACTURER_CONTACT_ZIP_EXT
MANUFACTURER_G1_ADDRESS_1
String AV. JUSCELINO KUBITSCHEK DE
MANUFACTURER_G1_ADDRESS_2
String OLIVEIRA, 3291 CIC
MANUFACTURER_G1_CITY
String CURITIBA
MANUFACTURER_G1_COUNTRY
String BR
MANUFACTURER_G1_NAME
String JJGC S.A.
MANUFACTURER_G1_POSTAL_CODE
String 81270-200
MANUFACTURER_G1_STATE
String PR
MANUFACTURER_G1_ZIP_CODE_EXT
Integer -200
MANUFACTURER_G1_ZIP_CODE
Integer 81270
MANUFACTURER_LINK_FLAG
Boolean t
DATE_MANUFACTURER_RECEIVED
DISTRIBUTOR_NAME
DISTRIBUTOR_ADDRESS_1
DISTRIBUTOR_ADDRESS_2
DISTRIBUTOR_CITY
DISTRIBUTOR_STATE
DISTRIBUTOR_ZIP_CODE
DISTRIBUTOR_ZIP_CODE_EXT
SUMMARY_REPORT_FLAG
Boolean f
REPORT_NUMBER
String 3008261720-2024-001524
SOURCE_TYPE
String """["Foreign","Health Professional"]"""
HEALTH_PROFESSIONAL
Boolean t
PATIENT
String """[{"date_received":"20240624","patient_age":"56 YR","pa...
ADVERSE_EVENT_FLAG
Boolean t
REPORT_SOURCE_CODE
String Manufacturer report
SUPPL_DATES_MFR_RECEIVED
PMA_PMN_NUMBER
String K163194
NUMBER_PATIENTS_IN_EVENT
EVENT_LOCATION
String OTHER
REPORT_TO_MANUFACTURER
NOE_SUMMARIZED
Integer 1
MDR_REPORT_KEY
Integer 19599291
PREVIOUS_USE_CODE
String I
MDR_TEXT
String """[{"mdr_text_key":"345467169","patient_sequence_number"...
NUMBER_DEVICES_IN_EVENT
PRODUCT_PROBLEMS
String """["Failure to Osseointegrate"]"""
REPORT_TO_FDA
Boolean f
PRODUCT_PROBLEM_FLAG
Boolean f
TYPE_OF_REPORT
String """["Initial submission"]"""
REPORTER_COUNTRY_CODE
String RS
REPORTER_OCCUPATION_CODE
String DENTIST
DATE_REPORT_TO_FDA
DATE_REPORT_TO_MANUFACTURER
SINGLE_USE_FLAG
Boolean t
REMOVAL_CORRECTION_NUMBER
SUPPL_DATES_FDA_RECEIVED
REPROCESSED_AND_REUSED_FLAG
Boolean f
EVENT_KEY
REMEDIAL_ACTION
String """[""]"""
DATE_FACILITY_AWARE
DateTime 2024-06-24T00:00:00+00:00
CREATED_AT
String 2024-09-29 13:13:08.996 -0700
UPDATED_AT
String 2024-09-29 13:13:08.996 -0700

Description

FDA Medical Device Data by Dataplex, featuring 24M rows of updated data, formatted in CSV. Covering 9 essential device data types, including recalls, premarket approvals, and enforcement actions, this product data is crucial for regulatory compliance, market analysis, and safety evaluation.
The FDA Device Dataset by Dataplex provides comprehensive access to over 24 million rows of detailed information, covering 9 key data types essential for anyone involved in the medical device industry. Sourced directly from the U.S. Food and Drug Administration (FDA), this dataset is a critical resource for regulatory compliance, market analysis, and product safety assessment regarding. Dataset Overview: This dataset includes data on medical device registrations, approvals, recalls, and adverse events, among other crucial aspects. The dataset is meticulously cleaned and structured to ensure that it meets the needs of researchers, regulatory professionals, and market analysts. 24 Million Rows of Data: With over 24 million rows, this dataset offers an extensive view of the regulatory landscape for medical devices. It includes data types such as classification, event, enforcement, 510k, registration listings, recall, PMA, UDI, and covid19 serology. This wide range of data types allows users to perform granular analysis on a broad spectrum of device-related topics. Sourced from the FDA: All data in this dataset is sourced directly from the FDA, ensuring that it is accurate, up-to-date, and reliable. Regular updates ensure that the dataset remains current, reflecting the latest in device approvals, clearances, and safety reports. Key Features: - Comprehensive Coverage: Includes 9 key device data types, such as 510(k) clearances, premarket approvals, device classifications, and adverse event reports. - Regulatory Compliance: Provides detailed information necessary for tracking compliance with FDA regulations, including device recalls and enforcement actions. - Market Analysis: Analysts can utilize the dataset to assess market trends, monitor competitor activities, and track the introduction of new devices. - Product Safety Analysis: Researchers can analyze adverse event reports and device recalls to evaluate the safety and performance of medical devices. Use Cases: - Regulatory Compliance: Ensure your devices meet FDA standards, monitor compliance trends, and stay informed about regulatory changes. - Market Research: Identify trends in the medical device market, track new device approvals, and analyze competitive landscapes with up-to-date and historical data. - Product Safety: Assess the safety and performance of medical devices by examining detailed adverse event reports and recall data. Data Quality and Reliability: The FDA Device Dataset prioritizes data quality and reliability. Each record is meticulously sourced from the FDA's official databases, ensuring that the information is both accurate and up-to-date. This makes the dataset a trusted resource for critical applications, where data accuracy is vital. Integration and Usability: The dataset is provided in CSV format, making it compatible with most data analysis tools and platforms. Users can easily import, analyze, and utilize the data for various applications, from regulatory reporting to market analysis. User-Friendly Structure and Metadata: The data is organized for easy navigation, with clear metadata files included to help users identify relevant records. The dataset is structured by device type, approval and clearance processes, and adverse event reports, allowing for efficient data retrieval and analysis. Ideal For: - Regulatory Professionals: Monitor FDA compliance, track regulatory changes, and prepare for audits with comprehensive and up-to-date data. - Market Analysts: Conduct detailed research on market trends, assess new device entries, and analyze competitive dynamics with extensive FDA data. - Healthcare Researchers: Evaluate the safety and efficacy of medical devices product data, identify potential risks, and contribute to improved patient outcomes through detailed analysis. This dataset is an indispensable resource for anyone involved in the medical device industry, providing the data and insights necessary to drive informed decisions and ensure compliance with FDA regulations.

Country Coverage

North America (1)
United States of America

History

48 years of historical data

Volume

24 M+ records
7 GB+ and growing
600 + attributes
48 Years of historical data
9 data types

Pricing

Free sample available
Dataplex has not published pricing information for this product yet. You can request detailed pricing information below.

Suitable Company Sizes

Small Business
Medium-sized Business
Enterprise

Quality

Self-reported by the provider
100%
attributes consistent data types

Delivery

Methods
S3 Bucket
SFTP
Frequency
daily
weekly
monthly
yearly
Format
.csv

Use Cases

ESG Investing
Portfolio Construction
Quantitative Investing
ESG Performance Analysis
Equity Reseach

Categories

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Frequently asked questions

What is Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis?

FDA Medical Device Data by Dataplex, featuring 24M rows of updated data, formatted in CSV. Covering 9 essential device data types, including recalls, premarket approvals, and enforcement actions, this product data is crucial for regulatory compliance, market analysis, and safety evaluation.

What is Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis used for?

This product has 5 key use cases. Dataplex recommends using the data for ESG Investing, Portfolio Construction, Quantitative Investing, ESG Performance Analysis, and Equity Reseach. Global businesses and organizations buy Company IP Data from Dataplex to fuel their analytics and enrichment.

Who can use Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis?

This product is best suited if you’re a Small Business, Medium-sized Business, or Enterprise looking for Company IP Data. Get in touch with Dataplex to see what their data can do for your business and find out which integrations they provide.

How far back does the data in Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis go?

This product has 48 years of historical coverage. It can be delivered on a daily, weekly, monthly, and yearly basis.

Which countries does Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis cover?

This product includes data covering 1 country like USA. Dataplex is headquartered in United States of America.

How much does Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis cost?

Pricing information for Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis is available by getting in contact with Dataplex. Connect with Dataplex to get a quote and arrange custom pricing models based on your data requirements.

How can I get Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis?

Businesses can buy Company IP Data from Dataplex and get the data via S3 Bucket and SFTP. Depending on your data requirements and subscription budget, Dataplex can deliver this product in .csv format.

What is the data quality of Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis?

Dataplex has reported that this product has the following quality and accuracy assurances: 100% attributes consistent data types. You can compare and assess the data quality of Dataplex using Datarade’s data marketplace.

What are similar products to Dataplex: FDA Medical Device Data 24M+ Rows of Healthcare Device Data for Research & Analysis?

This product has 3 related products. These alternatives include McGRAW Ailment Healthcare Industry Leads Data 130 MM Ailment Records, Competitive Intelligence & Business Intelligence (BI) Data for B2B Companies I Business Data I Competitor Analysis, and Healthcare Data- Healthcare Contact Data, Healthcare Professionals Data, Scrape All Publicly Available Healthcare Related Data’s 50% Cost Saving. You can compare the best Company IP Data providers and products via Datarade’s data marketplace and get the right data for your use case.

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