Waismed Ltd.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2118-2025 | Class II | Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Sof | June 5, 2025 |
| Z-2119-2025 | Class II | Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Soft | June 5, 2025 |
| Z-2680-2016 | Class II | NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injec | August 18, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K211968 | NIO+ Adult | July 22, 2021 |
| K190538 | NIO-I | October 7, 2019 |
| K160805 | NIO-P | June 23, 2016 |
| K142086 | NIO -INTRAOSSEOUS DEVICE | August 28, 2014 |
| K062940 | BONE INJECTION GUN (B.I.G.) | December 22, 2006 |
| K022415 | BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST | October 11, 2002 |
| K981853 | BONE INJECTION GUN (B.I.G.) DEVICE | November 17, 1998 |