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FDA Inspection
•Atrium Medical Corporation•September 6, 2022

Atrium Medical Corporation – FDA Inspection, Sep 6, 2022

Record Details

This FDA Inspection record concerns Atrium Medical Corporation, with an inspection on September 6, 2022, issued by the Center for Devices and Radiological Health, covering devices.

Company
Atrium Medical Corporation
Inspection Date
September 6, 2022
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · f939fb2e-7d36-47dc-acc1-a22154e51cff

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1178933
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

Other FDA inspections of Atrium Medical Corporation

10
DateClassificationOfficeProject area
June 1, 2026Not classifiedNew England District OfficePostmarket Assurance: Devices
November 26, 2024NAINew England District OfficePostmarket Assurance: Medical Devices
February 10, 2020OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
August 2, 2018OAICenter for Devices and Radiological HealthProject Evaluation: Devices
July 13, 2016OAICenter for Devices and Radiological HealthCompliance: Devices
View all 10 other inspections on the company page
Other documents for Atrium Medical Corporation
  • FDA Inspection 1322014 - 2026-06-01
  • FDA Inspection 1232907 - 2024-11-26
  • FDA Inspection 1117399 - 2020-02-10
  • FDA Inspection 1060821 - 2018-08-02
  • FDA Inspection 977679 - 2016-07-13

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