FDA Inspection
Ulthera IncUlthera Inc – FDA Inspection, Nov 24, 2009
Record Details
This FDA Inspection record concerns Ulthera Inc, with an inspection on November 24, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ulthera Inc
- Inspection Date
- November 24, 2009
- Product Type
- Devices
View Company Profile
ID · 9ccc95d0-48db-4621-bd67-0ff2bb9e47c3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 633629
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Ulthera Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2025 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 22, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 18, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 26, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 23, 2017 | Not classified | Atlanta District Office |
Other documents for Ulthera Inc
- FDA Inspection 1290810 - 2025-10-28
- FDA Inspection 1209243 - 2023-06-22
- FDA Inspection 1103289 - 2019-09-18
- FDA Inspection 1060604 - 2018-07-26
- FDA Inspection 1029899 - 2017-06-23
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