Company · US
Pearl, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 2025 | K250525 | Second Opinion® Panoramic Pearl, Inc. | MYN |
| Jun 12, 2025 | K243234 | Second Opinion® CS Pearl, Inc. | MYN |
| May 23, 2025 | K243989 | Second Opinion® 3D Pearl, Inc. | QIH |
| May 9, 2025 | K243230 | Second Opinion® BLE Pearl, Inc. | QIH |
| May 5, 2025 | K243893 | Second Opinion® Pediatric Pearl, Inc. | MYN |
| Apr 11, 2025 | K242600 | Second Opinion Periapical Radiolucency Contours Pearl, Inc. | MYN |
| Jan 16, 2025 | K242522 | Second Opinion CC Pearl, Inc. | MYN |
| Mar 4, 2022 | K210365 | Second Opinion Pearl, Inc. | MYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||