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  1. Find information on medical devices cleared by FDA through the 510 (k) process. Search by panel, 510 (k) number, product code or device name and see summary or statement, decision, classification and more.

  2. 1 dzień temu · 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...

  3. Search the 510(k) Premarket Notification database. You can also download zipped 510(k) files for specific time periods. General Information. Medical Device Safety and the 510(k) Clearance...

  4. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.

  5. Access the Food and Drug Administration's database for 510(K) premarket notifications, showcasing device safety and effectiveness.

  6. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device...

  7. 25 lis 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...

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