510(k) Search

Search FDA's Web Site for Cleared Reprocessed Single-Use Devices (SUDs)

FDA’s Searchable 510(k) Database allows you to search for medical devices that FDA has cleared under the 510(k) process, including reprocessed single-use devices.

Information which can be useful to search for a reprocessed SUDs include:

• Reprocessed SUD product codes found in List 1, List 2, and Attachment 1 in the September 29, 2005, Federal Register Notice [Text];
• Name of device - trade name under which the device is marketed;
• Applicant of the submission (See list of known reprocessors);
• 510(k) Number;
• Date of decision.

You may have to try several ways of searching the database. It is usually best to complete only one box in the online search form per search. The search engine searches for an exact match of text. Therefore, one descriptive word in the "device name" box is recommended.

Please note that the 510(k) database contains original application information only. That is, the 510(k) database maintains the name of the original applicant and the original trade name provided in the 510(k). It is not updated to reflect the current owner or distributor of the product nor any changes in trade name.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm