FDA Inspection
Biodex Medical Systems, Inc.Biodex Medical Systems, Inc. – FDA Inspection, Jun 20, 2013
Record Details
This FDA Inspection record concerns Biodex Medical Systems, Inc., with an inspection on June 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biodex Medical Systems, Inc.
- Inspection Date
- June 20, 2013
- Product Type
- Devices
View Company Profile
ID · ea42d0e9-8cfe-4c13-b958-7e35e490d9c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837929
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.40(b)Change records, content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biodex Medical Systems, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 1, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 4, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 22, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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