Company ยท KR
Poonglim Pharmatech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2024. Name variants (Inc, Corp, punctuation) are merged.
6510(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 29, 2024 | K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe Poonglim Pharmatech, Inc., KR | QNQ |
| Sep 15, 2023 | K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe Poonglim Pharmatech, Inc., KR | QNQ |
| Feb 16, 2021 | K210444 | EZ-Injec LDV Sterile Safety Needle Poonglim Pharmatech, Inc., KR | QNS |
| Feb 16, 2021 | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe Poonglim Pharmatech, Inc., KR | QNQ |
| May 12, 2020 | K192222 | EZ-Inject Single use Needle Poonglim Pharmatech, Inc., KR | FMI |
| Jun 21, 2018 | K172483 | Kopac Sterile Needle Poonglim Pharmatech, Inc., KR | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||