Premarket Search
iOS app by Chris Carcerano. Reference · Chris Carcerano
- Store rating
- 5 / 5
- Store rating count
- 1
- Download price
- Free to download
- In-app purchases
- Unknown
- Version
- 2.2
- Listing last refreshed
- 2026-09-18
View the original store listing
Store description excerpt
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-mont
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