Is Boston Scientific Corporation FDA approved?

Boston Scientific Corporation holds 3 FDA-registered establishments across 3 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Boston Scientific Corporation's drugs manufactured?

At registered sites in the United Kingdom, Ireland, the United States. The FDA register lists Farnham; Cork; Quincy, MA. Registered operations: labelling, finished drug manufacture.

What drugs does Boston Scientific Corporation make?

2 products are listed under Boston Scientific Corporation in the openFDA NDC Directory, most often as kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Boston Scientific Corporation

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 3
Active NDC listings: 2
Live patents: 2
Countries: 3
Base: United States

Authorisation

Registered operations

Labelling3Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Biocompatibles UK LtdRegistrant: Boston Scientific Corporation	Chapman House Farnham Business Park Weydon Lane, Farnham, Surrey GU9 8QL, United Kingdom (GBR)	Labelling, Finished drug manufacture	3002124543222870839
BOSTON SCIENTIFIC LIMITEDRegistrant: Boston Scientific Corporation	Cork Business & Technology Park Model Farm Road, Cork, Co. Cork T12 YK88, Ireland (IRL)	Labelling, Finished drug manufacture	3002913962986120235
Boston Scientific Corporation	500 Commander Shea Blvd, Quincy, Massachusetts (MA) 02171, United States (USA)	Labelling	3001451463603515370

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
kit	2

Route	NDCs

Labeller name on the listing	NDCs
boston scientific corporation	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7814943	VARITHENApolidocanol	product	Nov 2027
9480652	VARITHENApolidocanol	product	May 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Varithena	polidocanol	kit	60635-118NDA
Varithena	polidocanol	kit	60635-133NDA

Neighbours

Registered in the same town

SGS North America Inc.Cork, IRL

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Aurolife Pharma LLC3 sites · 70 NDC
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Enquiry

Common questions

Is Boston Scientific Corporation FDA approved?: Boston Scientific Corporation holds 3 FDA-registered establishments across 3 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Boston Scientific Corporation's drugs manufactured?: At registered sites in the United Kingdom, Ireland, the United States. The FDA register lists Farnham; Cork; Quincy, MA. Registered operations: labelling, finished drug manufacture.
What drugs does Boston Scientific Corporation make?: 2 products are listed under Boston Scientific Corporation in the openFDA NDC Directory, most often as kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.