- Medical Device Owner Operator
- MD Establishment Owner Operator
- Owner Operator MD
- Establishment Owner Operator
- Medical Device Operators
- Medical Device Establishment Owners
Medical Device Establishment Owner Operator
The U.S. Food and Drug Administration (FDA) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA.
The operators of such establishments are found in this dataset.
Get The Data
- ResearchNon-Commercial, Share-Alike, Attribution Free Forever
- CommercialCommercial Use, Remix & Adapt, White Label Log in to download
All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee. The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012.
This official list of operator is updated weekly according to FDA releasing.
About this Dataset
John Snow Labs; U.S. Food and Drug Administration (FDA);
|Source License URL|
|Source License Requirements||
Owner Operator MD, Establishment Owner Operator, Medical Device Operators, Medical Device Establishment Owners
Medical Device Owner Operator, MD Establishment Owner Operator
|Registration_Key||Registration Key of the Establishment||integer||level : Nominalrequired : 1|
|Contact_Id||Contact Id||integer||level : Nominal|
|Owner_Operator_Number||Owner Operator Number||string||-|
|Registration Key||Contact Id||Firm Name||Owner Operator Number|
|5||948632||BARNHARDT MFG. CO.||1010842|
|6||948632||BARNHARDT MFG. CO.||1010842|
|21||948646||MEDICAL SPECIALTIES, INC.||1016498|
|51||2916370||Smith & Nephew, Inc.||1020279|
|55||2916370||Smith & Nephew, Inc.||1020279|
|79||948692||PROFESSIONAL PRODUCTS, INC.||1026765|
|145||2926635||HEIDELBERG MEDICAL, INC.||1031128|
|155||1954733||PETER BRASSELER HOLDINGS, L.L.C.||1032227|