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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2023 | Stryker Corporation Triton Canister Software
Catalog Number: GAUS-2.
Intended adjunct in the estimation of blood loss. Open, Classified |
PBZ | K142801 |
| Feb 27, 2023 | Stryker Corporation Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L
Catalog Number: FG 12022.
Intended adjunct in the estimation of blood loss. Open, Classified |
PBZ | K142801 |
| Feb 27, 2023 | Stryker Corporation Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L
Catalog Number: FG 12010.
Intended adjunct in the estimation of blood loss. Open, Classified |
PBZ | K142801 |
| Jan 22, 2020 | Stryker Instruments Div. of Stryker Corporation Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation o Terminated |
PBZ | K142801 |
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