FDA-Registered Medical Device Contract Manufacturers
2,056 U.S. device facilities tell FDA they manufacture for someone else. This page shows where they are and which ones have public compliance records. It does not tell you who has capacity—or who you should hire.
The number behind the directory
A record counts only when its FDA activity explicitly says “Manufacture Medical Device for Another Party (Contract Manufacturer).”
All 49 states and territories represented
Facilities with public compliance profiles
These matching establishments also have public inspection, Form 483, warning-letter, or recall evidence in FacilityLedger.
Registration is the first check. Not the last.
- Confirm that the FDA activity matches the work you plan to outsource.
- Review the establishment's inspection classifications and Form 483 history.
- Check warning letters and recalls for recurring quality-system issues.
- Verify product-area experience, certifications, capacity, and quality-agreement responsibilities directly with the facility.
FDA registration is not approval, certification, or proof that the plant is taking new work.
Frequently asked questions
What does FDA call a medical-device contract manufacturer?
The activity is 'Manufacture Medical Device for Another Party (Contract Manufacturer).' It says what the facility registered to do. It says nothing about available capacity.
Does FDA registration qualify a contract manufacturer?
No. Registration is the first check. You still need the manufacturing scope, quality agreement, inspection history, Form 483s, warning letters, recalls, certifications, capacity, and references.
Are drug contract manufacturers included?
Drug manufacturers are searchable, but FDA drug registration data does not reliably identify customer relationships. FacilityLedger will not call a drug plant a contract manufacturer without a source that says so.
How this page was made
The directory is filtered from FDA's explicit device-establishment activities. Compliance profiles appear only where the imported public record has an inspection, Form 483, warning letter, or recall.
Source: FDA public data · status as of 2026-08-22