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Sep 30, 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 years. Reports older than ten years are provided on the FDA's MDR Data Files webpage.
Sep 30, 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 years. Reports older than ten years are provided on the FDA's MDR Data Files 32 webpage.
Sep 30, 2024 · The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
How is the MAUDE Database Full Text Search Index searched? Because of the amount of MAUDE data, you must select the 2-year period in which to search. Your search term can be the exact name of a specific device, or it can be a more generic, common name for a category of devices (i.e. pacemaker) or other search term.
Oct 28, 2024 · A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
4 days ago · Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device Classification; FDA Guidance Documents ; Humanitarian Device Exemption ; Medsun Reports; Premarket Approvals (PMAs) Post-Approval Studies; Postmarket Surveillance Studies; Radiation-Emitting Products
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Oct 28, 2024 · It includes information about Device Classification Product Codes, Premarket Approvals (PMA), Premarket Notifications (510[K]), MAUDE Medical Device Adverse Event Reports, and CDRH Medical Device Recalls.
Please note that medical device reports that have been received through the MedSun program are included in the Manufacturer and User Facility Device Experience (MAUDE) Database, which continues to be regularly updated.
Common Search Operators. AND finds documents containing both words it joins. (e.g., pregnancy AND folate will find all documents containing pregnancy and folate.) OR finds documents containing either of the words it joins. (e.g., pregnancy OR folate will find documents containing the word pregnancy or the word folate, but not necessarily both.)
