Numed Inc
FDA Regulatory Profile
Numed Inc appears in FDA public data with 3 recalls, 49 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1754-2025, Class II) was initiated on Apr 21, 2025. Its most recent 510(k) clearance was granted on Jan 12, 2022.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 49
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1754-2025 | Class II | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 | Apr 21, 2025 |
| Z-0510-2019 | Class II | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for u | Oct 17, 2018 |
| Z-0511-2019 | Class II | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for u | Oct 17, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213915 | BIB Stent Placement Catheter | Jan 12, 2022 |
| K211910 | Z-6 Atrioseptostomy Catheter | Jul 19, 2021 |
| K211134 | BIB Stent Placement Catheter | May 27, 2021 |
| K190974 | D'Vill Introducer | May 14, 2019 |
| K171206 | D'Vill Introducer | Oct 20, 2017 |
| K161451 | BIB Stent Placement Catheter | Sep 22, 2016 |
| K160598 | REBOA Balloon Catheter | Jun 20, 2016 |
| K160889 | BIB Stent Placement Catheter | May 20, 2016 |
| K131869 | PTS-X SIZING BALLOON CATHETER | Aug 8, 2013 |
| K122012 | Z-MED Z-MED II | Oct 4, 2012 |
| K121859 | TYSHAK NUCLEUS | Aug 31, 2012 |
| DEN080015 | NUCLEUS-X PTV CATHETER | Jun 11, 2012 |
| K110903 | PTS-X SIZING BALLOON CATHETER | Apr 29, 2011 |
| K102473 | MULLINS-X PTV CATHETER | Dec 9, 2010 |
| K082868 | MULLINS-X, MODEL 250X | Oct 24, 2008 |
| K082524 | MINI GHOST, MODEL: 507 | Sep 26, 2008 |
| K081680 | NUCLEUS-X, MODEL 230X | Jul 10, 2008 |
| K051343 | MINI GHOST PTA CATHETER, MODEL 507 | Jul 28, 2005 |
| K050857 | BIB PTA BALLOON CATHETER | Jul 28, 2005 |
| K040830 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | Jun 18, 2004 |