Premarket Search

New: PMA approvals search offline, live FDA recall search, and openFDA context on every record — linked recalls, adverse events, registration, and UDI devices.

Premarket Search puts the U.S. FDA's medical device databases in your pocket — 175,000+ 510(k) clearances and 56,000+ PMA approvals, searchable in milliseconds, entirely offline. Built for regulatory affairs, device engineering, research, market analysis, and clinical practice. No account, no sign-in.

THREE FDA PATHWAYS • 510(k) premarket notifications — 175,000+ cleared devices, bundled offline • PMA premarket approvals — 56,000+ Class III approvals and supplements, bundled offline • Device recalls — searched live against the FDA's public openFDA API (internet required)

SEARCH INSTANTLY • Full-text search across the bundled dataset in milliseconds, with type-ahead matching • Find 510(k)s by device name, applicant company, contact, product code, or K-number • Find PMAs by trade name, generic name, applicant, or PMA number • Search recalls by firm, product, reason, root cause, product code, K-number, PMA number, or recall number • Choose which fields to search, and sort by relevance, date, company, or name • Every result shows the review time and how long ago the device was cleared

STRUCTURED FILTERS (510(k)) • Narrow by review panel (medical specialty), product code, and submission type • Filter by decision outcome — substantially equivalent, De Novo, or other • Constrain decision or received dates and min/max review days • Filter third-party review and applicant state or country • Run filters alone or combine them with free-text search

BROWSE BY CODE OR COMPANY • Explore 7,000+ product codes with device class, 21 CFR regulation, clearance count, latest decision, and average review time • Browse applicant companies and open a full clearance timeline for any firm • Jump from a product code or company straight into filtered search

EVERY RECORD IN FULL • Device name, K-number or PMA number, and the clearance or approval decision • Applicant company, contact, and address; submission and decision dates; review time • Product code, review panel, submission type, and third-party review status • Open the official FDA summary PDF or the FDA device page inside the app

LIVE openFDA CONTEXT (internet required) Every 510(k) and PMA record can pull public FDA context on demand: • Product-code classification — device class, regulation, implant and life-sustaining flags • Linked device recalls, with the full recall record in-app • High-level MAUDE adverse-event counts, with sample reports • FDA establishment registration & listing for the applicant, with Open in Maps • GUDID commercial device entries for the premarket number

LIBRARY, COMPARE & EXPORT (510(k)) • Star favorites and organize named collections with personal notes • Revisit recent searches from on-device history • Compare up to four clearances side by side • Export results or full records as CSV, JSON, or Markdown

STATISTICS • A dashboard of 510(k) trends over the last 1, 3, 6, 12, 18, or 24 months • Devices reviewed, average and median days to review, and the busiest month • Reviews-per-month and average-review-time charts • Submission-type mix, busiest specialties, De Novo count, and third-party share

BUILT FOR SPEED & PRIVACY • 510(k), PMA, and product-code data search completely offline — the bundled dataset lives on your device • Recall search and the live context sections contact the FDA's public servers (api.fda.gov, accessdata.fda.gov). Those requests carry no account, identifier, or personal data • No analytics, no advertising, no tracking, and no data collection of any kind • Favorites, collections, and history never leave your device • Clean, modern design with full VoiceOver and Dynamic Type support

Premarket Search is not affiliated with, sponsored by, or endorsed by the U.S. Food and Drug Administration. All data is sourced from the FDA's publicly available 510(k), PMA, and device-classification files and from the public openFDA APIs, and is provided for informational purposes only.