What does Devices@FDA do?
Devices@FDA provides one place where you can find official information about FDA cleared and approved medical devices.
You can use Devices@FDA to:
- Find out if and when medical devices were cleared or approved by FDA
- Read summaries of medical devices currently on the market
- Get phone numbers and addresses of medical device companies
- Read and print patient information and instructions for use
- Learn about changes to devices since they were approved
What products are in Devices@FDA?
Devices@FDA contains all products found in the PMA, 510(k), and HDE databases. This includes all medical devices that were reviewed and cleared or approved by FDA.
What products are not in Devices@FDA?
FDA does not review every medical device. Some lower-risk devices are "exempt" from FDA review if they meet certain criteria. Those devices are not in Devices@FDA.
What information is available for each product in Devices@FDA?
For each product, you can find:
- Device name
- Device summary information
- Date approved or cleared
- Summary of safety and effectiveness (when available)
- Professional and patient user instructions (when available)
- Any FDA-prepared consumer information (when available)
- Any supplements (changes) to a PMA or HDE product since it was first approved
- FDA Press releases
How do the searches work in Devices@FDA?
When you enter a search term in Devices@FDA, the program searches three FDA databases (510(k), PMA, HDE) to find the search term in the device name, company, or summary information. It returns all records containing the search term.
- Your search term can be the exact name of a specific device, or it can be a more generic, common name for a category of devices (i.e. pacemaker).
- Search terms are not case sensitive.
For example, search terms like MediValv, medivalv, Medivalv and MEDIVALV will all find the same set of records.
- Normally, Devices@FDA uses a process called stemming to find your search term. In stemming, all words that are based on your search term are also included.
For example, if you Search with hear, you will get all records that have one or more words that stem from hear, like hears or hearing. You will not get records that have heart in them because hear is not a stem of heart.
- Or, you may use an * to indicate that you would like Devices@FDA to search all words containing your original search term and not use stemming. This is a good strategy to use if you are not exactly sure what a device is called. You may use * at the beginning, end, or beginning and end of your search term.
For example, if you search with hear*, you will get all records that have one or more words that start with hear, such as hear, heart, hearing, hears and hearth. If you search with *ear you will words that end in ear, such as clear, hear, smear, etc, but not heart, hearing, hears, and hearth. If you search with *ear* you get records that have one or more words with ear somewhere in them, such as clear, hear, smear, heart, hearing, hears, hearth, etc.
As yet another example, if you are interested in finding all angiography devices, they may be listed under angiogram, angiography, or angiographic device. If you entered angiogr* you would get all of the devices. If you entered angiogram, you would get only some of the devices.
- Trade names are often made-up words. If you are not sure of the spelling of a trade name for a specific device, you should add the * following 3-5 letters of the word rather than guessing at the spelling of the trade name.
For example, if you want to find the device Medivalv, you would not find the record if you entered Medivalve, but you would it if you searched with Medi*.
- You may enter more than one word in the search box if you would like to limit your search to records that contain all words.
For example, if you search with heart valve, you will get only those records that have both heart and valve in them. The records do not have to have the words near each other in the record.
- The program automatically includes all approval dates. If you like, you can select a time period of device approval.
- The program automatically returns 10 records per page. You can change this to a different number if you like.
- The program automatically sorts your results by approval date. You can change this to sort by device name if you like.
Once you have entered your search conditions, click on "Search." Depending on your internet connection, it may take up to several minutes to complete your search.
How are the results displayed?
You will receive a list of up to 500 records meeting your search criteria. From this list, you can select a device name, company name, or other link for further information. If you would like to change the order of this list, you can select an up or down arrow next to table heading for device name, company, or date approved.
If you need to see more than the maximum 500 records allowed in a search,
- Set the number of records per page to 500.
- Set sort by "Approval Date."
- Run the first search.
- Get the approval date for the 500th record from the bottom of the first results page.
- Open another browser window and search in it using the approval date for that 500th record for the "To" date.
- If you need to, export the results to Excel spreadsheets and copy and paste them together.
Some medical devices have supplements. Supplements indicate some type of change in a PMA or HDE device since it was approved. If the device listing states "Supplements available," you can click on this link to get a list of all available supplements.
Remember, if a record indicates that supplements are available, you should always read them to learn about changes in the user instructions, warnings, risk and benefit information, device name, or company.
What else can I get on this site?
At the bottom of the device list pages, you will find options to search the FDA web site further for your specific search terms.
- If you select Search Entire FDA web, you will get a list of every time your search term was mentioned in any FDA document.
- If you select Search only Press Releases, you will get a list of all press releases issued that contain your particular search term.
- If you select Search only Enforcement Reports, you will get a list of FDA actions (including recalls and safety alerts) that contain your particular search term.
How can I get further assistance?
If you have additional questions about a specific device, you can contact CDRH’s Consumer Staff.
When corresponding or requesting information from the CDRH Consumer Staff, please include your telephone and FAX numbers, mailing/E-mail address in your request.
If you have questions or feedback about Devices@FDA, please use this link to contact us: mailto:email@example.com.