Company
United StatesBiodex Medical Systems, Inc., Shirley, NY – FDA Inspections
Inspection records and compliance data for Biodex Medical Systems, Inc. in Shirley, New York. 6 FDA inspections on record, 2 Form 483s, last inspected February 10, 2023.
Company Profile
This profile covers Biodex Medical Systems, Inc. based in Shirley, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected December 22, 2011. Last inspected February 10, 2023.
Most cited issue areas
- DHR - not or inadequately maintained3 inspections
- Report of Death or Serious Injury2 inspections
- Adverse events--all info not in file1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 10, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1199302 |
| May 1, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1050414 |
| March 17, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 918132 |
| June 20, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 837929 |
| April 4, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 775740 |
| December 22, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 761505 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biodex Medical Systems, Inc.
FEI Number
2431314
Address
49 Natcon Dr, Shirley, New York 11967, United States
Country
United States
ID: 436949c2-cd7a-4818-8f55-0f99e731ff60