Search every U.S. FDA device database, profile any firm's compliance history, catch safety signals, and get alerted the moment a competitor clears a device or a supplier gets a Warning Letter — all in one place.
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Fast, filterable tables across every key device database — export to CSV or PDF in one click.
510(k), PMA, GUDID (UDI), product codes, regulation numbers (21 CFR), establishment registration & listing, and 25M+ adverse-event reports (MDR/MAUDE) — all searchable and cross-linked.
Type a firm (or click any FEI number) to instantly see its entire FDA history — establishment listings, 510(k)s, PMAs, Warning Letters, 483s, inspections, recalls and import refusals in one view. Perfect for supplier due-diligence — and one click turns any company into a monitored watch.
Disproportionality analysis over 25M+ adverse-event reports — surfaces the device problems reported far more often than expected, an early warning of a safety signal.
Browse FDA Form 483 observations, Warning Letters, inspection outcomes (NAI/VAI/OAI), import refusals and device recall enforcement — the signals that reveal quality risk.
The most-cited 483 observations, recalls by class, and the firms with the most Warning Letters — visual analytics to benchmark risk and prep for your next inspection.
Get notified when a new 510(k), listing or GUDID device appears — or when a company you track gets a new Warning Letter, recall, 483 or import refusal. On-screen and by email.
Register your products and continuously check FDA recalls and adverse-event reports (MAUDE/AEMS), with a monthly summary email and PDF report.
Visualize the 510(k) predicate chain up to three levels deep to find the best predicate and understand the competitive landscape.
KPIs and trend charts across your watches and monitored products. Export any filtered table to CSV/Excel or generate a PDF in one click.
Look up any device, company or product code across the FDA databases with instant filtering — no more juggling separate FDA sites.
Add your products, suppliers and competitors. QARACloud watches the FDA for new clearances, recalls, complaints and Warning Letters on your behalf.
Receive alerts and monthly reports by email, and export board-ready CSV/PDF whenever you need to share findings.
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