Check the FDA or Health Canada public record on one medical device.
$199. 2 business days. Source-backed.
TrueMedDevice prepares a Public Regulatory Status Snapshot for one product, one manufacturer, one jurisdiction. Every claim links to the official FDA or Health Canada source — your team can verify everything we cite. Prepared by an analyst, delivered as a PDF in 2 business days.
Public-data-based research and review support — not a regulatory, legal, import, purchasing, or compliance decision. Final decisions remain with your qualified RA/QA, regulatory, legal, or procurement professional.
One device. One public-record check. One source-backed PDF.
Fixed price: $199 USD per jurisdiction. Delivery: 2 business days from payment. Prepared by an analyst (not auto-generated). One round of clarification email is included if we need more identifiers to match your product to the public record. Full refund if we cannot reliably match — see Refund & clarification policy.
Who this is for
Importer / distributor
“Before I sign a distribution agreement, I want to see what FDA / Health Canada actually publishes about this device — registration, clearance, recalls, adverse-event signals, warning letters, import alerts.”
Start Status Snapshot →Hospital procurement / sourcing
“When my team evaluates a vendor or a vendor-proposed product, the public FDA / Health Canada record is the first thing we want to see. Pulling it together by hand takes hours.”
Start Status Snapshot →Founder vetting a supplier
“Before I commit to a contract manufacturer or component supplier, I want to see their FDA registration, their clearance history, their public quality signals.”
Start Status Snapshot →Investor doing quick screening
“For pre-LOI / pre-IOI medical-device screening, the public FDA / Health Canada record is the cheapest piece of diligence I can run before committing more capital.”
Start Status Snapshot →When to use it
- Before signing a distribution, sourcing, or supplier agreement.
- Before committing procurement budget for a new vendor or vendor-proposed device.
- Before issuing a Letter of Intent or Indication of Interest in a medical-device deal.
- Before approving a new component supplier or contract manufacturer.
- Whenever you need a defensible, dated, source-backed snapshot of what FDA or Health Canada has actually published about one device.
What you submit
Required (5 fields)
- • Jurisdiction (United States or Canada)
- • Product name
- • Manufacturer
- • Reason for check
Optional (raises Report Readiness)
More identifiers help us match public records more reliably. If you don't have them, the form provides a copyable checklist you can email to your supplier or RA/QA colleague.
- • 510(k) / PMA / De Novo number, FDA product code (US)
- • MDL licence number, MDEL holder, device class (Canada)
- • Model / catalog number, product page or brochure URL
- • Vendor / distributor name (if different from manufacturer)
What we search
United States — FDA public databases
- 1. FDA Product Classification
- 2. FDA 510(k)
- 3. FDA PMA
- 4. FDA De Novo (manual lookup)
- 5. FDA Establishment Registration & Listing
- 6. FDA CDRH Recalls
- 7. FDA Enforcement Reports (openFDA)
- 8. FDA Warning Letters (manual lookup)
- 9. FDA MAUDE Adverse Event Reports
- 10. FDA Safety Communications
- 11. FDA Import Alerts & Refusals (manual lookup)
Canada — Health Canada public databases
- 1. HC Medical Device Active Licence Listing (MDALL)
- 2. HC Medical Device Listing (MDL)
- 3. HC Medical Device Establishment Licence (MDEL) (manual lookup)
- 4. HC Recalls and Safety Alerts
- 5. HC Medical Device Vigilance / Incident Reports (manual lookup)
- 6. HC Advisories / Safety Communications
- 7. Drug and Health Products Portal (cross-reference)
What the PDF includes
- Cover with report ID, jurisdiction, product, manufacturer, report-issued date, search scope, and per-source as-of date table.
- Executive Snapshot — clearance / authorization indicators, recall / enforcement signals, MAUDE or vigilance signal, safety communications, import alerts, matching confidence, red flags for professional review.
- Identification & search keys used — verbatim, so your professional can replicate the search.
- Source results table — one row per source with search key, result, source URL, source-record ID, as-of date, limitation note.
- Matching confidence summary — L1 / L2 / L3 / L4 / L5 with rationale.
- What was found / what was not found / what this does NOT mean — explicit, scoped, and bounded.
- Recommended next checks — suggestions for your RA/QA, regulatory, legal, or procurement professional.
- Recommended Next Questions for the supplier / manufacturer / RA-QA. Public identifiers and publicly-shareable documents only.
- Source appendix — every URL we cite.
- Limitations and disclaimer — per-source limitations and the standard service-boundary statement.
See an actual sample
The sample is a real-record US Status Snapshot anchored on a real, publicly registered Class II medical device family (Volumetric Infusion Pump, FDA product code FRN, regulation 21 CFR 880.5725) from a long-established US-active manufacturer. Every source URL links to the live FDA database where you can verify each claim independently.
View sample (US, real-record)Inclusion of the worked example is not a comment on the manufacturer's quality, compliance posture, or product safety — it reflects long-standing public FDA presence and position as one of several major US-active manufacturers in the category.
What this does NOT mean
A Status Snapshot is a public-record check. It is not:
- — a compliance certificate
- — a legal opinion
- — an import authorization or determination
- — a purchasing recommendation
- — a safety verdict
- — a vendor approval or disapproval
- — a substitute for your qualified RA/QA, regulatory, legal, or procurement professional
The phrases “this product is compliant,” “legal to import,” and “safe to purchase” do not appear in any Status Snapshot — they are not the kind of statement we make. Words like “approved,” “cleared,” and “licensed” appear only when directly citing an official source's exact term, accompanied by the official identifier and the source URL.
Service boundary
What this service is. TrueMedDevice prepares a Public Regulatory Status Snapshot based on public FDA and Health Canada databases. Each Status Snapshot organizes information from named public sources into a structured, source-backed PDF for one product, one manufacturer, one jurisdiction. Every claim links to its official source.
What this service is not. TrueMedDevice does not provide regulatory advice, legal advice, clinical advice, import authorization, purchasing recommendation, compliance certification, or quality-system certification. We do not determine whether a device complies with any regulation. We do not guarantee approval, clearance, licence, or compliance. We do not replace your qualified RA/QA professionals, regulatory consultants, or legal counsel. We do not reproduce the body text of copyrighted standards.
Limitations of public data. Public databases lag actual events. MAUDE adverse-event reporting is voluntary and is known to under-represent actual event frequency. Health Canada recall publication can lag manufacturer notification by 2–6 weeks. Absence of evidence in a public database is not evidence that an event did not occur. Every Status Snapshot names its per-source as-of date.
Final decisions. Every regulatory, classification, pathway, registration, recall-response, CAPA, MDR, vigilance, import, sourcing, procurement, or purchasing decision based on the contents of a Status Snapshot remains the responsibility of the buyer and the buyer's qualified RA/QA, regulatory, legal, or procurement professional. Our reports are research and review support. They are not the decision.
Refund & clarification policy
If we cannot reliably match your inputs to public records, we will email you within 1 business day with a short clarifying question. If the match still cannot be resolved, you will receive a full $199 refund (default), or — if you prefer — a report explicitly stating that no public records were matched. Your choice.
Clarification is one round. If you choose the no-match-resolved report instead of the refund, that's documented at delivery; otherwise the refund is processed within 5 business days.
FAQ
What is a “Public Regulatory Status Snapshot”?
A 5–8 page PDF report covering one device — what FDA or Health Canada has publicly published about it. Every claim links to the official source database. The Snapshot organizes the public record; it does not interpret compliance, safety, or commercial fit.
Is this a compliance certificate?
No. A Status Snapshot is not a compliance certificate, not a regulatory determination, not a legal or import opinion. It is a source-backed public-record check that supports your qualified professional's review. The phrase “compliance certificate” appears nowhere in our reports.
What if you can't find my product?
If matching confidence falls to L2 or L1, our analyst sends one clarifying email within 1 business day. If clarification can't resolve the match, you receive a full refund (default), or — if you'd rather — a report explicitly stating that no public records were matched. See Refund & clarification policy.
What if I don't know all the identifiers?
The required fields are jurisdiction + product name + manufacturer + email + reason for check. The optional identifier fields raise your Report Readiness — they help us match your inputs more reliably, but they're not required. The form also includes a copyable checklist you can email to a supplier or RA/QA colleague.
Do you cover EU MDR, UKCA, Australia TGA, China NMPA?
Not in v1. A Status Snapshot is jurisdiction-scoped to one of United States or Canada per order. Other jurisdictions are out of scope at this price tier. Each jurisdiction is a separate $199 order.
How long does the report take?
2 business days from payment. If we need a clarifying email, the SLA pauses while we wait for your reply, then resumes. We always confirm the date of delivery in the order confirmation email.
Can I get a refund?
Yes — full refund if we cannot reliably match your product to public records. See Refund & clarification policy.
Who prepares the report?
A TrueMedDevice analyst, working from public FDA / Health Canada databases. The pipeline is manual / semi-AI / analyst-reviewed — we use machine assistance to organize the searches, but every claim and every source citation is reviewed by a human analyst before the PDF is delivered.
Why is the price fixed at $199?
Because the SKU is fixed at one product, one manufacturer, one jurisdiction, one search, one PDF. A fixed price keeps the offer simple, makes the budget approval-friendly, and removes negotiation friction.
Ready to start?
One product, one jurisdiction, $199 USD, 2 business days.
Start Status Snapshot