Company ยท KR
Hans Biomed Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (1 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 |
|---|---|---|---|
| Sep 18, 2026 | K254238 | MINT MONO Sutures Hans Biomed Corporation, KR | NEW |
| Mar 7, 2023 | K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 101 Hans Biomed Corporation, KR | NEW |
| Sep 9, 2020 | K192423 | MINT Product Family Hans Biomed Corporation, KR | NEW |
| Feb 22, 2018 | K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty Hans Biomed Corporation, KR | MQV |
| Apr 21, 2016 | K152077 | MaxiGen Hans Biomed Corp., KR | MQV |
| Mar 11, 2016 | K151271 | BellaFuse Hans Biomed Corp., KR | MQV |
| Jan 10, 2014 | K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY Hans Biomed Corp. | NUN |
| Jun 12, 2013 | K130191 | MINT Hans Biomed Corporation | NEW |
| Nov 15, 2012 | K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY Hans Biomed Corp. | MBP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||