| Database |
Comments |
| 510(k)s Database
|
This is an Access 97 file containing a listing of all 510(k)s through
March 8, 2004. If you are
tired of staring at all capitalized letters and not being able to look at the data in
tabular format when using the FDA 510(k) database, then this file is for you. If the
response to this file is good I will up-date it on a monthly basis. Email me if I get lazy
about this. |
| 510(k)s Database |
Download files containing all releasable 510(k)s |
| Approved PMAs
and PDPs |
Download a zipped file containing all releasable Premarket Approval and
Product Development Protocols. |
| Medical Device
Product Codes |
Download a file containing the medical device product codes and federal
register citations. If you can't decipher the information go to the "file description" link on the same
page. |
| Medical Device Reports
(Download) |
This page contains links to MDR files that may be downloaded in
pipe-delimited zipped format. Warning! Large Files. |
| Releasable
Establishment Registration and Device Listing Files |
The Medical Device Establishment Registration Master File contains the
required information submitted by owner/operators of medical device establishments in
accordance with Section 510 of the Federal Food, Drug and Cosmetic Act. |
