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30 de abr. de 2024 · The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten...
- Standards
Medical Device Reports (MAUDE) CDRH Export Certificate...
- CLIA
Aquí nos gustaría mostrarte una descripción, pero el sitio...
- Adverse Events
The Manufacturer and User Facility Device Experience (MAUDE)...
- Download Files
The FDA will continue to seek ways to improve the MAUDE...
- MDR Data Files Webpage
Like all MDR data in MAUDE, MDR data in ASR reports cannot...
- Cdrh FOIA Electronic Reading Room
Aquí nos gustaría mostrarte una descripción, pero el sitio...
- Post-Approval Studies
Mandated Studies Program Food and Drug Administration 10903...
- De Novo
In 1997, the Food and Drug Administration Modernization Act...
- Standards
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About . MAUDE Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
