Acro Biomedical Co., Ltd.
Kaohsiung, TW
ACRO BIOMEDICAL CO., LTD. appears in FDA device records in Kaohsiung, TW. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. 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 4 510(k) clearances for Acro Biomedical Co., Ltd. between 2017 and 2024. The busiest year on record is 2017, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233378 | ABCcolla® Collagen ADM Scaffold | KGN | Substantially Equivalent | |
| K212156 | ABCcolla Bone Matrix | MQV | Substantially Equivalent | |
| K171629 | ABCcolla Bone Graft | MQV | Substantially Equivalent | |
| K162348 | ABCcolla Collagen Matrix | KGN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014982332 | 3014982332 | ACRO BIOMEDICAL CO., LTD. | 3rd Fl., No.57, Luke 2nd Rd., Luzhu Dist., Kaohsiung 82151 TW | 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