FDA Device Entity Profile: ATRIUM MEDICAL CORPORATION

Known Identifiers & Locations

FEI Numbers 3011175548

Owner Operator Numbers 1219977

Locations Covered Merrimack, NH, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3011175548	Atrium Medical Corporation	Merrimack, NH, US	Develop Specifications But Do Not Manufacture At This Facility	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (3)

Recall #	Product Description	Initiation Date	Status	Action
Z-0019-2011	HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124 Reason: Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters.	2010-08-10	Terminated	View Details
Z-0020-2011	HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132 Reason: Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters.	2010-08-10	Terminated	View Details
Z-0024-2025	iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 Reason: There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.	2024-09-09	Open, Classified	View Details

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