
Premarket Search
FDA 510(k), PMA & recalls
About
Quickly search and explore over 175,000 FDA 510(k) cleared medical devices. Access detailed information, statistics, and insights offline. Ideal for professionals and researchers in the medical device industry.
What's New in Premarket Search
2.2
August 9, 2026
TWO NEW WAYS TO SEARCH • PMA approvals, offline — search 56,000+ Class III Premarket Approvals and supplements by trade name, generic name, applicant, or PMA number, with the full approval record: supplement type and reason, advisory committee, device class, regulation, and AO statement • Device recalls, live — search the FDA's public recall database by firm, product, reason, root cause, product code, K-number, PMA number, or recall number, and read the full recall record in-app (internet required) • Switch between 510(k), PMA, and Recalls right from the results list — each mode has its own search fields and sorting LIVE FDA CONTEXT ON EVERY RECORD (internet required) • Product-code classification — device class, 21 CFR regulation, implant and life-sustaining flags • Linked recalls and high-level MAUDE adverse-event counts, with sample reports • FDA establishment registration & listing for the applicant, with Open in Maps • GUDID commercial devices for the premarket number • Each section now loads independently, so one slow lookup no longer holds up the others SEARCH FIXES • Product Code is now its own 510(k) search field. Previously it only matched as a side effect of having every field switched on, so turning off an unrelated field silently dropped thousands of matches • Recall search now ranks the firm you actually typed first, and firm names containing "&" ("Smith & Nephew") return results instead of an error • Decision-date and date-received filters were off by one day for users east of UTC • A partly-typed search is no longer ignored when a filter is active • "Search this company" no longer permanently overwrites your saved search-field settings • Recent searches now restore the filters they were run with, and one typed phrase no longer fills history with half-typed entries BROWSE, LIBRARY & COMPARE • Company browse no longer splits the same firm into duplicate rows with mismatched counts • Browse lists now say when results are capped instead of showing a total that doesn't match • Product-code rows show device class and 21 CFR regulation number • You can remove a device from a collection again — swipe the row • Adding to Compare from Browse works, and tells you when the compare basket is full • Tapping a device in Browse reliably opens its record ACCESSIBILITY • VoiceOver reads each result as one clear sentence instead of fragment by fragment • Decision status now has its own icon, so it never depends on colour alone • Charts, browse rows, statistics cards, and identifiers stay readable at the largest text sizes • Higher-contrast detail text, labelled loading indicators, and bigger tap targets in the filter and compare bars PERFORMANCE & POLISH • Large exports, PDF sharing, and typing collection notes no longer freeze or stutter the app • Exported CSVs open safely in Excel and Numbers — text starting with =, + or - is no longer treated as a formula • On iPad, the detail pane no longer shows the previous device's record while the next one loads • FDA device pages that previously showed "Access Denied" now open in the in-app browser • Clearer empty states, including one for when recall search can't reach the FDA • About the data now lists 510(k), PMA, and product-code record counts and explains what works offline • Fresh FDA data with the latest clearances and approvals Thanks for using Premarket Search! Questions or ideas? Visit pocketfetch.com.
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FAQ
What is Premarket Search?
Premarket Search is a mobile application that provides offline access to the U.S. FDA's 510(k) premarket notification database. It allows users to search and explore over 175,000 cleared medical devices with detailed information.
Does Premarket Search have ads?
No, Premarket Search is ad-free. The app explicitly states it has no ads, ensuring an uninterrupted user experience.
What devices is Premarket Search available on?
Premarket Search is available on iPhone and iPad devices. It features a clean, modern design that adapts well to both screen sizes.
How often is Premarket Search updated?
The latest version of Premarket Search is 2.1.0, which was last updated on July 7, 2026. While specific update frequency isn't detailed, this indicates recent development activity.
Can I use Premarket Search offline?
Yes, Premarket Search is designed for offline use. The entire dataset of over 175,000 devices lives on your device, allowing you to search and browse without an internet connection.
Is there a cost to use Premarket Search?
No, Premarket Search is completely free to use. There are no charges associated with downloading or accessing its features.
What kind of data can I find in Premarket Search?
You can find comprehensive data for each cleared medical device, including the device name, K-number, applicant company, submission and decision dates, review time, product code, and the official FDA 510(k) summary PDF.
What are the statistics and insights offered by Premarket Search?
Premarket Search provides a dashboard with statistics such as total devices reviewed, average and median review days, reviews-per-month charts, submission-type mix, and busiest medical specialties, all filterable by time range.









