This page includes the latest FDA filings for Focus Surgery Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 2951226 |
| FEI Number | 3002132857 |
| Name | Focus Surgery, Inc. |
| Owner & Operator | SonaCare Medical, LLC |
| Contact Address | 10130 Perimeter Parkway Ste 250 Charlotte NC 28216 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 4000 Pendleton Way Indianapolis, IN 46226 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| FOCUS SURGERY INC | Sonablate Insertion Pack 403-14500-0003-BG | 2025-09-29 |
| FOCUS SURGERY INC | Sonablate System | 2025-09-01 |
| FOCUS SURGERY INC | Water Path Kit | 2024-12-17 |
| FOCUS SURGERY INC | Sonablate Insertion Pack | 2024-12-17 |
| FOCUS SURGERY INC | Water Path Kit | 2024-12-17 |
| FOCUS SURGERY INC | Sonablate Insertion Pack | 2024-12-17 |
| FOCUS SURGERY INC | Water Path Kit | 2024-12-17 |
| FOCUS SURGERY INC | Water Path Kit | 2024-12-16 |
| FOCUS SURGERY INC | Sonablate Insertion Pack | 2024-12-10 |
| FOCUS SURGERY INC | O-ring Applicator Tool | 2024-12-10 |
| FOCUS SURGERY INC | Sonachill | 2020-03-02 |
| FOCUS SURGERY INC | Sonablate Insertion Pack | 2019-02-08 |
| FOCUS SURGERY INC | Sonablate | 2018-03-29 |
| FOCUS SURGERY INC | Sonasource | 2018-03-29 |
Focus Surgery, Inc. [SonaCare Medical, LLC] | Sonablate | 2017-01-07 |
Focus Surgery, Inc. [SonaCare Medical, LLC] | Sonablate | 2015-10-22 |
| FOCUS SURGERY, INC. | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | 1994-04-18 |
| FOCUS SURGERY, INC. | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | 1992-10-29 |
| FOCUS SURGERY, INC. | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | 1992-03-26 |
| FOCUS SURGERY, INC. | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | 1992-03-01 |
| FOCUS SURGERY, INC. | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | 1991-12-20 |
| NCAGE Code | 3E6Y3 | FOCUS SURGERY INC |
| CAGE Code | 3E6Y3 | FOCUS SURGERY INC |
| DUNS | 101084143 | FOCUS SURGERY INC |