Panels › General Hospital › Product code PKP · Class 2
Immunoglobulin G (Igg) Infusion System
Regulation 880.5725
1510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PKP
| Company | 510(k)s | Recalls |
|---|---|---|
| Emed Technologies Corporation | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2025 | K251105 | Tetra (TM-20); Tetra (TM-50) Emed Technologies Corporation | PKP |
| Feb 16, 2024 | K240148 | SCIg60 Infusion System Emed Technologies Corporation | PKP |
| Nov 28, 2023 | K230883 | VersaPump Infusion System Emed Technologies Corporation | PKP |
| Oct 13, 2022 | K222087 | SCIg60 Infusion System Emed Technologies Corporation | PKP |
| Dec 14, 2018 | K173783 | SCIg60 Infusion System Emed Technologies Corporation | PKP |
| Dec 1, 2016 | K161906 | SCIg60 Infuser Emed Technologies Corporation | PKP |
| May 14, 2015 | K142319 | SCIg60 Infuser, Infuset Emed Technologies Corporation | PKP |
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