How we build and verify the directory

MedtechSourcebook is an independent directory built from FDA's public establishment registration and device listing data. It is not affiliated with the FDA, and it does not manufacture, broker or sterilize devices. This page describes the data as of FDA's export of Oct 21, 2026.

Who is listed

A facility is listed when it meets all of these conditions in FDA's data:

• It lists at least one device under one of FDA's two contract establishment types, quoted exactly: "Manufacture Medical Device for Another Party (Contract Manufacturer)" or "Sterilize Medical Device for Another Party (Contract Sterilizer)". FDA defines eleven establishment types; these are the only two for work done for another company. Facilities that only manufacture their own devices, relabel, repackage or develop specifications are not listed.
• Its registered address is in the United States, including Puerto Rico.
• Its registration is active and has an FDA registration number. FDA's data holds 96 US records "awaiting assignment of registration number" (19 of them contract listings), which carry no registration or FEI number; we leave them out until FDA assigns one.

From FDA listings to facilities

FDA publishes one record per device listing, not per company, so one facility can appear hundreds of times. The Oct 21, 2026 export holds 336,640 records, 157,074 of them in the US. We drop 5,423 US records that repeat another record exactly, then fold the rest into one facility per registration number. Where FDA gives two registration numbers the same FEI (FDA Establishment Identifier) number, we treat them as one facility and show both numbers; 1 listed facility is merged this way. The result is 2,282 facilities.

Device names, classes and categories come from FDA's product classification file. A facility's categories are FDA's classification panels (such as Orthopedic or Cardiovascular) of the product codes it lists as contract work. 5 listed product codes (LDQ, OPE, LOS, PBL, LDH) are not in FDA's classification file; they are shown by code only.

What "FDA-registered" means

Device facilities must register with FDA every year and list the devices they handle. Registration is a record that the facility told FDA what it does. In FDA's own words, "Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products" (21 CFR 807.39). Every registration number on this site links to FDA's record, and you can also look a facility up in FDA's registration and listing database.

Certifications

We hold no certification data yet, so every facility shows "Certification: not verified". When we add ISO 13485 or other certificates, a certificate will show as "company-stated" when it comes from the company's own website, and as "verified" only after we have found it on the certification body's own register, with a link to that record and the date we checked it.

Personal data

FDA's records name an official correspondent for each owner, and a US agent for foreign facilities, with phone numbers and email addresses. Our pipeline discards those fields when it reads the file, so they are neither stored nor published. We show company names, registered business addresses and FDA's registration data only.

Which pages search engines may index

We publish few pages for search engines at first, and only where the data supports a distinct page. The rule today:

• Establishment-type pages: indexed with at least 25 facilities.
• Device-category pages (FDA panels): built from 5 facilities, indexed from 25; 19 of 19 are indexed.
• Product-code pages: built from 5 facilities. A page is indexed only with at least 50 facilities, when its facility list overlaps no larger indexed product-code page by more than 50% (Jaccard similarity), and when it is among the 3 largest such pages in its FDA panel. 19 of 1,258 are indexed.
• State pages: built from 5 facilities, indexed only once 5 facilities in the state are verified. None is verified yet, so none of the 45 state pages is indexed.
• Facility profiles: not indexed until they carry more than FDA's own record (verified certificates or capabilities).

Pages outside the rule are still published for visitors, marked "noindex", and left out of the sitemaps.

Updates and corrections

We check openFDA every week and rebuild the directory when FDA publishes a new export. Facilities change their own entries by updating their registration and listing with FDA; the change reaches this site with the next export. A corrections form for anything else is on its way.