Hans Biomed Corp.
Daejeon, KR
HANS BIOMED CORP. appears in FDA device records in Daejeon, KR. FDA records list 8 510(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 8 510(k) clearances for Hans Biomed Corp. between 2012 and 2023. The busiest year on record is 2016, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 | NEW | Substantially Equivalent | |
| K192423 | MINT Product Family | NEW | Substantially Equivalent | |
| K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | MQV | Substantially Equivalent | |
| K152077 | MaxiGen | MQV | Substantially Equivalent | |
| K151271 | BellaFuse | MQV | Substantially Equivalent | |
| K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | NUN | Substantially Equivalent | |
| K130191 | MINT | NEW | Substantially Equivalent | |
| K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | MBP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003828812 | 3003828812 | HANS BIOMED CORP. | 64, YUSEONG-DAERO 1628 BEON-GIL, Daejeon 34054 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NUNBone Grafting Material, Human Source
- GEACannula, Surgical, General & Plastic Surgery
- MDAElastomer, Silicone, For Scar Management
- MQVFiller, Bone Void, Calcium Compound
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- GDFGuide, Needle, Surgical
- GDLNeedle, Suturing, Reusable
- GAHStylet, Surgical, General & Plastic Surgery
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- NEWSuture, Surgical, Absorbable, Polydioxanone
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