FDA Device Entity Profile: Avalign Technologies

Known Identifiers & Locations

FEI Numbers 1000069183, 1421101, 3004215117, 3007290840, 3008864603

Owner Operator Numbers 10051835

Locations Covered Fort Wayne, IN, US; Mentor, OH, US; SCHAUMBURG, IL, US; Schaumburg, IL, US; TUTTLINGEN Baden-Wurttemberg, DE

Registered Establishments (5)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1421101	Instrumed International Inc dba Avalign German Specialty Instruments	SCHAUMBURG, IL, US	Repack or Relabel Medical Device	View Details
1527105	AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC	Mentor, OH, US	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US	Repack or Relabel Medical Device	View Details
3008864603	AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
8010372	Instrumed GmbH dba Avalign German Specialty Instruments	TUTTLINGEN Baden-Wurttemberg, DE	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.