Company · KR
Plasmapp Co,., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2023. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 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 |
|---|---|---|---|
| May 25, 2023 | K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT9 Plasmapp Co,., Ltd., KR | MLR |
| May 9, 2023 | K223025 | Tyvek Roll with CI for STERLINK Sterilizer Plasmapp Co,., Ltd., KR | FRG |
| May 9, 2023 | K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), T Plasmapp Co,., Ltd., KR | FRC |
| May 9, 2023 | K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette Plasmapp Co,., Ltd., KR | MLR |
| Apr 14, 2023 | K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Plasmapp Co,., Ltd., KR | MLR |
| Oct 22, 2021 | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette Plasmapp Co,., Ltd., KR | MLR |
| Oct 22, 2021 | K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer Plasmapp Co,., Ltd., KR | FRG |
| Oct 22, 2021 | K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), T Plasmapp Co,., Ltd., KR | FRC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||