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CVRx, Inc., Minneapolis, MN – FDA Inspections

Inspection records and compliance data for CVRx, Inc. in Minneapolis, Minnesota. 4 FDA inspections on record, 1 Form 483, last inspected January 12, 2018.

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Company Profile

This profile covers CVRx, Inc. based in Minneapolis, Minnesota, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
2
NAI
1
Unclassified
1
Form 483s
1
Warning letters
0

First inspected November 18, 2009. Last inspected January 12, 2018.

Most cited issue areas

  • Sponsor notification of IRB approval withdrawal1 inspection
  • Sponsors" general responsibilities1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
January 12, 2018Not classifiedMedical Devices & Rad Health1088890
July 16, 2015VAIMedical Devices & Rad Health · Bioresearch Monitoring935008
May 31, 2012NAIMedical Devices & Rad Health · Compliance: Devices785234
November 18, 2009VAIMedical Devices & Rad Health · Bioresearch Monitoring628243
FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

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R4 Vascular Inc
Rochester Medical Corp
Jodi S. Michaels, M.D.
Medical Innovations International Inc.
RJC Products
Company Information

Name

CVRx, Inc.

FEI Number

3007972010

Address

9201 W Broadway Ave Ste 650, Minneapolis, Minnesota 55445, United States

Country

United States

ID: fbd5a1b7-f6ae-4327-8868-c073d18d89f8

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