Data / Medical devices / South Korea / BM Korea Co., Ltd.
BM Korea Co., Ltd.: FDA-registered device maker in Gunpo-si Gyeonggi, South Korea, 2 510(k) clearances
BM Korea Co., Ltd. is registered with the FDA (registration 3009475067) in Gunpo-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 16, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009475067
- Address
- Rm, 101, Ivalley Gunpo, Gongdan-ro 149, Gunpo-si Gyeonggi, South Korea, 15845
- Owner or operator
- BM KOREA CO., LTD. (10039124)
- Roles
- Manufacturer
- First device listed
- December 9, 2011
- Registered through
- 2026
- Brand names listed
- GUARDIAN Balloon Catheter, GUARDIAN Bone Access Needle, GUARDIAN Bone Filler Device, GUARDIAN Drill, GUARDIAN Inflatable Bone Expander System, GUARDIAN Inflation Syringe, GUARDIAN Osteo Introducer System, GUARDIAN-MD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Manufacturer | accessdata.fda.gov |
| Device, Percutaneous, Biopsy | MJG | 1 | Manufacturer | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 16, 2015 | K143006 | GUARDIAN-SG Inflatable Bone Expander System | NDN | Substantially Equivalent | Bm Korea Co., Ltd. | accessdata.fda.gov |
| November 18, 2011 | K111593 | GUARDIAN INFLATABLE BONE EXPANDER SYSTEM | NDN | Substantially Equivalent | Bm Korea Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Arthroscope
- All makers of Cement, Bone, Vertebroplasty
- All makers of Mixer, Cement, For Clinical Use
- All makers of Device, Percutaneous, Biopsy
Updated January 16, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.