Medicore Co. Ltd.
Seongnam-si Gyeonggi, KR
MEDICORE CO. LTD. appears in FDA device records in Seongnam-si Gyeonggi, KR. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Medicore Co. Ltd. between 1981 and 2021. The busiest year on record is 1981, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1988 | 1 |
| 1999 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212412 | IRIS-XP | LHQ | Substantially Equivalent | |
| K110374 | MAX PULSE SYSTEM | JOM | Substantially Equivalent | |
| K073323 | SA-3000P | JOM | Substantially Equivalent | |
| K983430 | LITE-TOUCH SYRINGE | FMF | Substantially Equivalent | |
| K880869 | MEDI-LET | FMK | Substantially Equivalent | |
| K810681 | MEDI-LANCE | FMK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2000010846 | 2000010846 | MEDICORE CO. LTD. | No. 801 803, Joonganginnotech, 148, Sagimakgolro,, Seongnam-si Gyeonggi 13207 KR | 2026 | |
| 3016511680 | 3016511680 | MEDICORE CO., LTD. | 47-13, Yongjeonggyeongje-ro 1-gil, Pocheon-si Gyeonggi 11154 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain