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FDA Inspection
•Atrium Medical Corporation•July 13, 2016

Atrium Medical Corporation – FDA Inspection, Jul 13, 2016

Record Details

This FDA Inspection record concerns Atrium Medical Corporation, with an inspection on July 13, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company
Atrium Medical Corporation
Inspection Date
July 13, 2016
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 41b3f73a-636b-486f-ab68-60bd973a8e7e

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
977679
FDA center
Medical Devices & Rad Health
Project area
Compliance: 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
September 6, 2022VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
February 10, 2020OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
August 2, 2018OAICenter for Devices and Radiological HealthProject Evaluation: 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 1178933 - 2022-09-06
  • FDA Inspection 1117399 - 2020-02-10
  • FDA Inspection 1060821 - 2018-08-02

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