FDA Device Entity Profile: Dornier MedTech America, Inc.

Known Identifiers & Locations

FEI Numbers 1037955

Owner Operator Numbers 1037955

Locations Covered KENNESAW, GA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1037955	DORNIER MEDTECH AMERICA, INC.	KENNESAW, GA, US	Complaint File Establishment per 21 CFR 820.198	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K083258	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30	Substantially Equivalent	View Details

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.