FDA lists 27 medical device databases, but six answer most questions: Product Classification, 510(k), De Novo, MAUDE, Recalls, and Registration & Listing. Each one answers a different question, and each has limits you need to know before you draw conclusions from it.
Key takeaways
- FDA lists 27 medical device databases. Most update weekly, AccessGUDID updates daily, and the recognized standards database updates quarterly.
- On September 24, 2026, FDA's openFDA data held 176,140 510(k) records, 7,093 product codes and more than 26 million adverse event reports.
- Dental implants produced 25.8% of the 2.89 million adverse event reports FDA received in 2025, and two manufacturers filed 68% of them. FDA says these reports cannot be used to compare event rates.
- 254 establishments in South Korea with current FDA registrations list dental implants, third behind the US (764) and Switzerland (265).
- Registration does not mean approval. Under 21 CFR 807.39, implying that it does is misbranding.
Which FDA database answers which question?
Start from your question, not from the database. This table matches common questions to the database that answers them, with the update schedule FDA gives for each [1].
| Your question | Database | Updated |
|---|---|---|
| What class is my device, and which rules apply? | Product Classification | Weekly |
| Which devices has FDA cleared, and which could be my predicate? | Premarket Notifications (510(k)s) | Weekly |
| Which new device types has FDA granted? | De Novo | Weekly |
| Which high-risk devices has FDA approved? | Premarket Approvals (PMA) | Weekly |
| What problems have been reported? | MAUDE | Weekly |
| Which devices were recalled, and why? | Recalls of Medical Devices | As items become available |
| Who is registered to make or import a device? | Registration & Listing | Weekly |
| Which standards does FDA recognize for testing? | Recognized Consensus Standards | Quarterly |
| What is this device's UDI record? | AccessGUDID | Daily |
| What do all of these say about one device type? | Total Product Life Cycle (TPLC) | Weekly |
| Is this FDA export certificate valid? | Export Certificate Validation | Weekly |
Source: FDA's Medical Device Databases page, content current as of April 6, 2022 [1].
Devices@FDA searches the 510(k) and PMA databases together [1]. FDA also keeps a separate list of AI-enabled devices [9], and our analysis of FDA's 1,614 AI-enabled devices shows where they cluster. Our 510(k) guide explains where each database fits in the submission process.
How big and how current is each database?
We checked openFDA, FDA's machine-readable copy of these databases, on September 24, 2026 [2].
| Database | Records | Last updated |
|---|---|---|
| 510(k) | 176,140 | September 14, 2026 |
| PMA, including supplements | 57,137 | September 14, 2026 |
| Product classification | 7,093 | September 14, 2026 |
| Adverse events (MAUDE) | 26,136,889 | September 8, 2026 |
| Recalls | 59,273 | September 24, 2026 |
| Registration & listing | 335,617 | September 14, 2026 |
| Device identifiers (GUDID) | 5,182,695 | September 2, 2026 |
Records are not all the same unit. A recall record is one recalled product, and one recall event can cover many products. A PMA record can be a supplement to an earlier approval.
Check the date before you rely on a result. On the day we checked, openFDA's copies ran up to about three weeks behind [2]. For anything recent, search FDA's own database pages as well.
How do you search the 510(k) database step by step?
Search by product code, not by device name. A product code groups every device of the same type, even when companies call them different things.
- Find your product code in the Product Classification database.
- Enter it in the 510(k) database and set a decision date range, such as the last five years, to focus on current predicates.
- Narrow the results with FDA's other search fields when they help: Applicant Name, Device Name, Third Party Reviewed, Clinical Trials and Predetermined Change Control Plan Authorized.
- Open each record. Note the decision date, the decision and whether the file has a 510(k) summary or a 510(k) statement.
For example, searching product code DZE for decisions made in 2025 returns the 31 dental implant clearances we counted [2].
Most clearances publish a summary. By our count, 96.4% of 510(k)s cleared in 2025 came with a 510(k) summary, and 3.6% with a statement [2]. A summary must explain the basis for the substantial equivalence decision and identify the predicate [10].
A statement still gives you a route to the data. The submitter certifies that it will make the safety and effectiveness information in its 510(k) available within 30 days of a request by any person [11]. If a key predicate has only a statement, ask for it.
How do you research a device across the databases?
Run one product code through several databases, then read the results together. Here is the root-form dental implant, product code DZE, checked on September 24, 2026.
| Database | What it showed for DZE |
|---|---|
| Product Classification | Class II under 21 CFR 872.3640, with a special controls guidance and 12 recognized standards; not eligible for Third Party Review [6] |
| 510(k) | 1,548 clearances in total, including 31 in 2025 with a median of 184 calendar days from receipt to decision [2] |
| Registration & Listing | 2,268 current registrations list DZE: 764 in the US, 265 in Switzerland and 254 in South Korea [2] |
| MAUDE | 745,835 reports received in 2025, 25.8% of all device reports that year [2] |
| Recalls | 11 recall events from 2020 to 2025; none with a recorded cause was a design problem [2] |
Read the results together. A crowded predicate field of 1,548 clearances makes a 510(k) the likely route. The 254 Korean registrations show how many Korean firms already list this device with FDA. The recall history points to manufacturing and packaging controls rather than design.
The MAUDE number needs care, which a later section explains.
If you manufacture in Korea, our guide on whether an MFDS licence helps with FDA clearance covers what transfers from a Korean file. To find the right product code in the first place, see our guide to FDA medical device classification.
Is there a faster way to search every database at once?
Yes. The dental implant above took five separate searches, each with its own search form and update schedule. Two tools cut that down.
FDA's free route covers part of it. The TPLC database combines PMA, 510(k), adverse event and recall data into one report, searched by device name or product code [1]. It is the best free starting point for an overview of one device type.
Complizen's Superagent brings the sources into one conversation. You ask a plain-English question, describe your device or enter a product code. It searches FDA's clearance, classification, adverse event, recall, guidance and standards records together, removes duplicates and ranks the results for your device. Its Predicate Finder ranks candidate predicates by similarity, and recalls come linked to their adverse event reports. Every answer is cited to the FDA record, so your team can check it. For the dental implant above, that means one question instead of five searches, and you can see it run on your own device in a 20-minute walkthrough.
What do recall classes mean?
FDA gives each recall a class from I to III, based on how serious the health hazard is [12]. Class I is the most serious.
| Recall class | FDA's definition, in short | Share of 2025 device recall reports |
|---|---|---|
| Class I | A reasonable probability of serious harm or death | 13.3% (377) |
| Class II | May cause temporary or medically reversible harm; serious harm is remote | 82.8% (2,350) |
| Class III | Not likely to cause adverse health consequences | 3.9% (110) |
Source: 21 CFR 7.3(m) [12]; our count of 2,837 device enforcement reports for recalls initiated in 2025, via openFDA [2].
Recall class is not device class. A recall's class describes the hazard in that recall. A Class II device can be part of a Class I recall. Our medical device recalls guide covers what a recall involves for the manufacturer.
What can the databases not tell you?
Every database has blind spots. Four matter most.
MAUDE counts are not rates. FDA says report data is not intended to evaluate adverse event rates or to compare them across devices, and that the incidence or cause of an event cannot be determined from reports alone [3]. Dental implants show why. They produced 25.8% of all device reports FDA received in 2025, and two manufacturers filed 67.6% of those [2]. That reflects how many implants are sold and how firms report, not which implant is riskiest. Superagent's MAUDE Analyst checks the adverse event signal on each predicate you are considering, which helps you read the reports in context.
Registration is not approval. Under 21 CFR 807.39, registration does not mean FDA approved the establishment or its products, and implying that it does is misbranding [4]. To confirm a device is cleared, check the 510(k) database. Our registration and listing guide explains what registration does cover.
You see only what FDA accepted. By our count, every one of the 3,225 decisions in FDA's 510(k) data for 2025 was a clearance or a De Novo grant [2]. Submissions that FDA turned down, or that were withdrawn, do not appear. A clean-looking predicate history can hide failed attempts.
The data lags. Most databases update weekly at best, and openFDA can run further behind [1, 2]. If you make devices, MAUDE is also where your own reports end up. Our MDR reporting guide covers what you must report and when.
How do you get FDA device data in bulk?
Use openFDA, FDA's free public API. Without a key, you can make 1,000 requests a day per IP address. With a free key, you can make 120,000 a day, at up to 240 requests a minute either way [5].
openFDA covers the core device datasets: 510(k), PMA, classification, adverse events, recalls, registration and listing, and UDI [2]. Every count in this article came from it. For predicate research at scale, pull all 510(k)s under your product code, then match each one to its recalls and reports. Our predicate device guide explains what makes a predicate defensible.
Which databases matter most if you manufacture outside the US?
Three deserve a regular check.
Registration & Listing. Search it by company name or device name, or use its advanced search. Confirm that your establishment, your devices and your US Agent all appear correctly, and check competitors the same way. FDA's own search page repeats that a listing does not denote approval [1]. Every foreign establishment must name a US Agent in its registration [8], and a device that needed a 510(k) is listed with its 510(k) number [7].
510(k), searched by applicant country. See what firms from your country have cleared, and under which product codes. By our count, FDA cleared 156 510(k)s for applicants based in South Korea in 2025 [2].
Export Certificate Validation. If a buyer or regulator abroad asks for proof of your FDA export certificate, this database shows which certificates are valid and not expired [1].
Our international path covers each priority market. When you know your product code, the free pathway finder shows which route to market fits your device.
Frequently asked questions
What is the FDA medical device database?
There is no single one. FDA lists 27 medical device databases, each covering one type of record, such as clearances, adverse events or recalls. Devices@FDA searches the 510(k) and PMA databases together, and openFDA offers the core device data through one free public API.
How do I search the FDA 510(k) database?
Search by product code for the most complete results, then narrow by device name, applicant or 510(k) number. A product code groups every device of the same type, so it catches devices sold under different names. Find your code in the Product Classification database first.
How often are FDA medical device databases updated?
Most update weekly, according to FDA's own list. AccessGUDID updates daily, recalls as items become available, and the recognized standards database quarterly. openFDA copies can lag further: on September 24, 2026, they ran up to about three weeks behind. For anything recent, check FDA's own pages.
Are FDA medical device databases free?
Yes. All of FDA's public device databases are free to search, and openFDA is a free public API. Without a key, openFDA allows 1,000 requests a day per IP address. A free key raises that limit to 120,000 requests a day.
What is MAUDE?
MAUDE is FDA's database of medical device reports: adverse events and malfunctions reported by manufacturers, importers, user facilities and others. It held more than 26 million reports in September 2026. FDA says the reports cannot be used alone to measure how often events happen.
Can I use MAUDE to compare device safety?
No. FDA states that report data is not intended to evaluate adverse event rates or to compare them across devices. Report volume reflects sales and reporting practice. In 2025, two dental implant manufacturers filed 68% of that device type's 745,835 reports.
How do I find my device's product code?
Search the Product Classification database by device name or keyword. Each entry gives the product code, regulation number, device class and submission type. Checking recent 510(k)s under the same code is a good way to confirm you have chosen the right one.
How do I check whether a company is registered with FDA?
Search the Registration & Listing database by company name, registration number or product code. It shows the establishment and the devices it lists, and foreign firms must name a US Agent. Registration alone does not mean FDA cleared or approved anything.
Does FDA registration mean a device is approved?
No. Under 21 CFR 807.39, registration does not denote approval of the establishment or its products, and implying that it does is misbranding. To confirm that a device is cleared or approved, check the 510(k), De Novo or PMA database.
What is the difference between the 510(k) database and Devices@FDA?
The 510(k) database covers premarket notifications only. Devices@FDA searches the 510(k) and PMA databases at once and links to summary information, the manufacturer and approval dates. Use Devices@FDA for a quick check across both routes. It does not cover De Novo requests, which have their own database.
What is the difference between a Class I, II and III recall?
Recall class shows how serious the hazard is. Class I means a reasonable probability of serious harm or death, Class II means temporary or reversible harm, and Class III means harm is unlikely. In 2025, 82.8% of device recall reports were Class II.
How do I find predicate devices in FDA databases?
Start with your product code in the 510(k) database and shortlist recent clearances with a similar intended use and technology. Read each 510(k) summary for the testing used; 96.4% of 2025 clearances published one. Then check MAUDE and Recalls for each candidate before you commit to it.
References
- FDA. Medical Device Databases. Content current as of April 6, 2022.
- openFDA. Device API. Checked September 24, 2026.
- FDA. Manufacturer and User Facility Device Experience Database (MAUDE). Accessed September 24, 2026.
- eCFR. 21 CFR 807.39, Misbranding by reference to establishment registration or to registration number. Accessed September 24, 2026.
- openFDA. Authentication. Accessed September 24, 2026.
- FDA. Product Classification Database entry for product code DZE. Checked September 24, 2026.
- FDA. Device Registration and Listing. Accessed September 24, 2026.
- eCFR. 21 CFR 807.40, Registration and listing of foreign establishments. Accessed September 24, 2026.
- FDA. Artificial Intelligence-Enabled Medical Devices. Accessed September 24, 2026.
- eCFR. 21 CFR 807.92, Content and format of a 510(k) summary. Accessed September 24, 2026.
- eCFR. 21 CFR 807.93, Content and format of a 510(k) statement. Accessed September 24, 2026.
- eCFR. 21 CFR 7.3, Definitions (recall classification). Accessed September 24, 2026.