For patients
Understand what a public signal does and does not prove.
Research medical-device signals before acting on risk.
Device records can be hard to interpret. Start with public recall and adverse-event signals, then use paid reports for citations and review context.
Search medical device adverse events, recalls, model signals, and source-backed device outcome intelligence.
Showing 12 device records. Use search, category, and sort to narrow the database.
Source-backed preview
GM HELIX ACQUA IMPLANT 3.5X13 MM
NEODENT - JJGC S.A. device event report from FDA MAUDE/openFDA; review identifiers and clinical context before acting.
- Status
- Injury
- Category
- Adverse event
- Risk
- Review
- Confidence
- 90
- Last seen
- 2026-05-18T02:47:49.557394Z
Medical-device data is source-backed intelligence for review. It is not a diagnosis, clinical recommendation, or proof of causation.
Paid device report includes
- Device or manufacturer signal snapshot
- Recall/adverse-event interpretation and clinical review checklist
- Source citations and source-observed dates
- Questions for clinicians, compliance teams, or counsel
Report access preview
$29.00 starting priceReports and workspace access are available through the main access flow after review. This page keeps record research display-only.
Use access for report, workspace, correction, claim, or API questions.Side-by-side comparison
Compare device records before reviewing report options.
Compare status, category, risk, and source confidence in one view. The paid report adds the locked citations and next-step checklist.
| device | Signal | Status | Risk | Confidence |
|---|---|---|---|---|
| GM HELIX ACQUA IMPLANT 3.5X13 MMNEODENT - JJGC S.A. device event report from FDA MAUDE/openFDA; review identifiers and clinical context before acting. | Injury | Adverse event | Review | 90 |
| SPECTRUM INFUSION PUMPBAXTER HEALTHCARE CORPORATION device event report from FDA MAUDE/openFDA; review identifiers and clinical context before acting. | Malfunction | Adverse event | Review | 90 |
| FREESTYLE LITEABBOTT DIABETES CARE INC device event report from FDA MAUDE/openFDA; review identifiers and clinical context before acting. | Malfunction | Adverse event | Review | 90 |
| SPECTRUM INFUSION PUMPBAXTER HEALTHCARE CORPORATION device event report from FDA MAUDE/openFDA; review identifiers and clinical context before acting. | Malfunction | Adverse event | Review | 90 |
| 630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO. device event report from FDA MAUDE/openFDA; review identifiers and clinical context before acting. | Malfunction | Adverse event | Review | 90 |
Why this database exists
Use Device Outcomes Registry without reading raw source rows.
patients, clinicians, hospitals, device companies, attorneys, and researchers need searchable source records, plain-English explanations, paid citations, and a clear escalation path when the public preview is not enough.
For clinicians
Use reports for inventory or chart review triage.
For compliance
Monitor model and manufacturer signals over time.
Coverage registry
Source names, source URLs, and citation paths are included in paid reports and workspace access. Medical-device data is source-backed intelligence for review. It is not a diagnosis, clinical recommendation, or proof of causation.
| Coverage group | Records source count | Max authority | Access |
|---|---|---|---|
| state source reference | 50 | 5/5 | Included in paid report |
| openfda device enforcement | 11 | 5/5 | Included in paid report |
| openfda device event | 11 | 5/5 | Included in paid report |
Research resources
Plain-English guidance for Device Outcomes Registry
These resources explain how to search the database, what paid reports add, and when source-backed records should be verified directly with the relevant authority.
Explore related paths
More ways to use this device profile
Facility Report Bundle
$29first report + $5 each additionalDevice or manufacturer signal snapshot Includes locked citations, interpretation, risk questions, and action checklist.
Request accessProfessional Workspace
$199per monthSession workspace for saved review context, report access, record review, correction/claim intake, and API access requests.
Request accessPortfolio Monitor
$899per monthPortfolio monitor setup for selected records, daily source refresh review, workspace review access, and escalation checklist.
Request accessEnterprise Onboarding
$2,500one timeEnterprise onboarding intake for custom coverage, users, API/report delivery, monitoring rules, and human QA workflow.
Request accessRequest access, corrections, claims, or API review.
High-impact use cases should request human QA before relying on automated source records.
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