Medical-device intelligence

The reference layer for medical devices.

Search any device. Verify any manufacturer. Surface the recall history, adverse-event signals, and regulatory pathway that the single-jurisdiction databases don’t carry — built for hospitals, researchers, manufacturers, and regulators who need answers, not headlines.

7.3M
Devices catalogued
17M+
MAUDE events
46K
Manufacturers
5
Regulators
Implantable cardiac · Class III · Pacemaker
Azure XT MRI
Medtronic, Inc. · FDA cleared
✓ MedevIQ verified
Recall! Class II2024 — battery-life software update, no patient action required.
MAUDE⚠ Signal1,247 reports · 2018–2024 · FDA event database
PathwayPMA P000026/S250 · cross-listed in EUDAMED · CDSCO Class D
23
Equivalent devices
5
Regulators
A1
Trust tier
Cross-referenced fromFDAopenFDAGUDIDMAUDEEUDAMEDCDSCOHealth CanadaTGAGMDNECRI
Coverage

Built on the largest unified medical-device data layer.

Every device, every manufacturer, every recall — reconciled across the FDA, EUDAMED, CDSCO, Health Canada, and TGA. The numbers below are the live silver-tier counts, not screenshots.

7.3M
Devices catalogued
FDA + EUDAMED + CDSCO + HC + TGA
17M+
MAUDE adverse events
openFDA event endpoint
46K
Manufacturers
canonicalised, cross-source
47K
Recalls + safety alerts
FDA + Health Canada combined
231K
Regulatory clearances
510(k) + PMA + Health Canada licences
1.7M
EU UDI-DI records
EUDAMED public registry
External-ID coverage

Linked into the global regulatory graph.

MedevIQ devices carry external identifiers that connect them across five regulators and the global nomenclature graph. Linkage rates below — current build.

UDI-DIFDA GUDID + EUDAMED unique device ID
96.4 %
FDA Product CodeopenFDA classification linkage
92.1 %
GMDNGlobal medical-device nomenclature
87.3 %
510(k) ReferencePredicate / clearance back-link
78.0 %
EUDAMED SRNEU manufacturer registration number
67.8 %
CDSCO Form IDIndian licence number cross-link
41.2 %
Capabilities

Beyond the regulator’s database.

The four categories of medical-device intelligence the public registries don’t carry. Cross-cutting, structured, queryable.

Cross-regulator device profiles

One profile per device, reconciled across FDA, EUDAMED, CDSCO, Health Canada, and TGA. Manufacturer, intended use, classification, regulatory pathway — joined at the device level, not chased across portals.

Adverse-event signal layer

MAUDE event reports surfaced device-by-device with disproportionality scoring, severity tiers, and date-of-event tracking. Real signals, not anecdote feeds.

Recall + FSCA tracking

FDA Class I/II/III recalls, Health Canada recalls, EUDAMED FSCAs (when published) — joined to the device record, with severity, root cause, and resolution status.

Manufacturer-canonical resolution

One company, hundreds of name variants. The canonical layer dedupes Medtronic Inc / Medtronic plc / Medtronic India / etc. into a single manufacturer ID — your queries don't get fragmented across spelling drift.

Every device. Every signal.

See the data your procurement decision deserves.

Each MedevIQ device page bundles classification, regulatory pathway, manufacturer history, equivalent-device graph, recall chronology, and adverse-event signals. One page, one source of truth.

  • Classification + regulatory pathway across regulators
  • Predicate / equivalent device graph
  • Recall chronology with root cause and severity
  • MAUDE adverse-event signals with disproportionality scores
  • Manufacturer canonical with full corporate history
  • Source attribution for every claim
medeviq.ai/device/ge-mac-2000-resting-ecg/
Diagnostic ECG · Class II · Cardiograph
MAC 2000 Resting ECG
GE HealthCare · FDA 510(k) K123456
PredicateMAC 1200 ST · substantially equivalent · 12-lead resting ECG
Equivalent18 cleared devices · Philips PageWriter, Mortara ELI 250c, Schiller AT-2 Plus
SourcesopenFDA 510(k) · GUDID · EUDAMED · CDSCO Class C
18
Equivalents
4
Regulators
A2
Trust tier
How it works

Three pieces. One coherent product.

01

Ingest authoritative sources

openFDA, EUDAMED, CDSCO, Health Canada, TGA, GUDID, MAUDE, plus device-classification taxonomies. Continuous refresh on a 90/180-day cycle for safety-critical fields.

02

Canonicalise at the manufacturer level

100K+ raw manufacturer name variants reconciled into ~46K canonical entities. Cross-walks across regulators happen at the manufacturer level, never at the spelling level.

03

Surface the intelligence layer

Classification, regulatory pathway, equivalent-device graphs, recall chronologies, and adverse-event signals — exposed via API and a queryable data product, not buried in PDFs.

Built for

People who buy, audit, or trust medical devices.

Hospitals

Procurement intelligence: equivalent-device graphs, recall history, manufacturer reliability, regulatory pathway.

Researchers

Structured access to a deduplicated cross-regulator device layer with source attribution and methodology transparency.

Manufacturers

Competitive intelligence, regulatory comparators, predicate-device graphs, post-market surveillance feeds.

Regulators / academic centers

Cross-source vigilance signals, recall chronologies, manufacturer-canonical reconciliation across jurisdictions.

Methodology

Every claim has a source. Every device has a regulatory anchor.

Tier-A profiles follow a 22-section playbook with explicit regulatory anchoring and source attribution. Safety-critical fields refresh every 60 days. The full operating contract is public.

Read the playbook →

Tier-A device profiles

Class III implantables get a 22-section profile with regulatory anchor, predicate graph, recall chronology, and post-market signal.

Source attribution per field

Each fact carries an attribution row — source, retrieval date, reviewer, decay clock. No claim is unsourced.

Trust tiers

Three explicit tiers: unverified (registry-only), AI-reviewed (cross-checked), expert-reviewed (signed off by clinical engineer).

Refresh cadence

Recall + adverse-event data: 60d. Regulatory + classification: 180d. Pricing: weekly. Last refresh shown on every page.

Early access

MedevIQ is in private preview.

We’re onboarding hospitals, researchers, manufacturers, and regulators in waves. Tell us about how you’d use MedevIQ and we’ll get back within a working week.

  • Verified researchers receive free access
  • Hospitals + manufacturers reviewed individually
  • Approval typically within 2 business days
  • No spam, ever

We review every request manually. Approved users typically hear back within 2 business days.