FDA Inspection
NDS Surgical Imaging LLCNDS Surgical Imaging LLC – FDA Inspection, Feb 13, 2026
Record Details
This FDA Inspection record concerns NDS Surgical Imaging LLC, with an inspection on February 13, 2026, issued by the Florida District Office, covering medical devices & rad health.
- Company
- NDS Surgical Imaging LLC
- Inspection Date
- February 13, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 78a70643-6159-4ffd-8c57-3e5d38392d9a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1302738
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
Full citation text and observation details available on the Dashboard.
Other FDA inspections of NDS Surgical Imaging LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 17, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 20, 2012 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| July 21, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 18, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for NDS Surgical Imaging LLC
- FDA Inspection 921173 - 2015-03-25
- FDA Inspection 793992 - 2012-08-17
- FDA Inspection 777976 - 2012-04-20
- FDA Inspection 673333 - 2010-07-21
- FDA Inspection 605685 - 2009-08-18
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.