Data / Medical devices / South Korea / Imedicom Co., Ltd.
Imedicom Co., Ltd.: FDA-registered device maker in Gunpo-si Gyeonggi, South Korea, 9 510(k) clearances
Imedicom Co., Ltd. is registered with the FDA (registration 3009599228) in Gunpo-si Gyeonggi, South Korea. It lists 17 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 6, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009599228
- Address
- #612, #709, #713, #804, #809, #815, 172, LS-ro, Gunpo-si Gyeonggi, South Korea, 15807
- Owner or operator
- IMEDICOM Co., Ltd. (10041241)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 4, 2012
- Registered through
- 2026
- Brand names listed
- B-Two Inflatable bone expander system balloon catheter, B-Two Inflatable bone expander system baloon catheter, B-Two Inflatable bone expander system syringe, B-Two Vertebral Balloon Expand® Kyphoplasty System, B-Two Vertebral access system, Brasseler EZX, Brasseler EZX Blade, EPINAUT and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 6, 2019 | K182287 | MEDINAUT Plus | HRX | Substantially Equivalent | Imedicom Co., Ltd. | accessdata.fda.gov |
| August 24, 2018 | K173541 | EPINAUT | BSO | Substantially Equivalent | Imedicom Co., Ltd. | accessdata.fda.gov |
| July 29, 2016 | K153296 | MEDINAUT Kyphoplasty System | NDN | Substantially Equivalent | Imedicom Co., Ltd. | accessdata.fda.gov |
| March 18, 2016 | K150915 | SPINAUT-P | GEI | Substantially Equivalent | Imedicom Co., Ltd. | accessdata.fda.gov |
| March 16, 2016 | K151268 | SPINAUT-V, SPINAUT-S, SPINAUT-I | HRX | Substantially Equivalent | Imedicom Co., Ltd. | accessdata.fda.gov |
| March 1, 2016 | K150789 | SPINAUT-E, SPINAUT-I | BSO | Substantially Equivalent | Imedicom Co., Ltd. | accessdata.fda.gov |
| April 4, 2014 | K133669 | MEDINAUT KYPHOPLASTY SYSTEM | NDN | Substantially Equivalent | Imedicom | accessdata.fda.gov |
| January 3, 2011 | K103433 | F20 | NDN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| March 17, 2006 | K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | NDN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
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Updated April 6, 2019. 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.