Data / Medical devices / United States / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in Roswell, GA, United States, 2 510(k) clearances

Name: Boston Scientific Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Boston Scientific Corporation is registered with the FDA (registration 3005619880) in Roswell, GA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 12, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005619880
Address: 1100 Old Ellis Rd Suite 1200, Roswell, GA, United States, 30076
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer, Specification developer
First device listed: May 22, 2026
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Collagen Surgical Mesh Containing Drugs	PIJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Manufacturer, Specification developer	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Manufacturer, Specification developer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 12, 2026	K262406	EluPro Antibiotic-Eluting BioEnvelope	FTM	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
June 15, 2020	K201313	CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)	FTM	Substantially Equivalent	Aziyo Biologics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 21, 2019	83652	Class II	Terminated	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (	Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.	accessdata.fda.gov

Compare with other makers

Updated August 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.