510(k) K211968 ยท FMI Needle, Hypodermic, Single Lumen
NIO+ Adult
| Applicant | Waismed, Ltd., Rosh Ha'Ayin, IL |
| Decision | Substantially Equivalent, Jul 22, 2021 |
| Received | Jun 24, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211968
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2025 | Waismed Ltd. Brand Name: NIO+
Product Name: NIO Intraosseous Device Adult
Model/Catalog Number: 105000908
Software Version: N/A
Product Description: NIO devices are a spring-based, automatic intraosseous access de Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.