Search the U.S. FDA and Brazil's ANVISA device databases, profile any firm's compliance history, track recalls and adverse events, 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.
Fast, filterable tables for every ANVISA database — export the filtered result to CSV/Excel in one click.
Registrations and notifications: product, active ingredient, marketing-authorization holder, regulatory category, therapeutic class, status and expiry.
Household sanitizing products with active or inactive registration, by product, company, process number and expiry date.
Registered and notified devices: technical and trade name, risk class, holder, manufacturer, country of origin and validity.
ANVISA's medical-device categories, with how many registrations and companies each one has and how many post-market reports it has accumulated — Brazil's equivalent of FDA product codes.
Reported adverse events and technical complaints (tecnovigilância) — by product, category, risk class, occurrence type, state and city. Brazil's equivalent of FDA MDR.
Precautionary measures published by ANVISA: bans, recalls and seizures — by product, company, risk and publication date.
Good Manufacturing, Distribution and Storage Practice certificates — who holds them, for what scope, until when, and whether they have expired.
Get notified of new registrations in your category, a supplier's GMP certificate, a precautionary measure or a post-market report — and when one of your registrations is about to expire.
Download the filtered result as CSV/Excel for your report, supplier due-diligence or regulatory dossier.
Look up any device, company, registration or product code across the FDA and ANVISA databases with instant filtering — no more juggling separate official sites.
Add your products, suppliers and competitors. QARACloud watches for new clearances and registrations, recalls, adverse events and enforcement on your behalf.
Receive alerts and reports by email, and export board-ready CSV/PDF whenever you need to share findings.
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Prices in Brazilian reais (BRL); taxes may apply.
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