Panels › General Hospital › Product code PBZ · Class 2
Image Processing Device For Estimation Of External Blood Loss
Regulation 880.2750
1510(k)s in 12 months (6 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in PBZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Gauss Surgical, Inc., | 4 | 0 |
| Stryker Corporation | 0 | 3 |
| Stryker Instruments | 2 | 0 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 16, 2026 | K252282 | SurgiCount+ System Stryker Instruments | PBZ |
| Jan 11, 2024 | K232250 | SurgiCount+ System Stryker Instruments | PBZ |
| Apr 25, 2017 | K163507 | Triton Sponge System Gauss Surgical, Inc., | PBZ |
| Aug 5, 2016 | K160338 | Triton System Gauss Surgical, Inc., | PBZ |
| Mar 12, 2015 | K142801 | Triton Canister System Gauss Surgical, Inc., | PBZ |
| May 9, 2014 | DEN130015 | PIXEL 3 SYSTEM Gauss Surgical, Inc., | PBZ |
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