Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Waismed with 7 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Jul 22, 2021: NIO+ Adult.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 22, 2021 | NIO+ AdultK211968 · FMI | 510(k) clearances |
| Oct 7, 2019 | NIO-IK190538 · FMI | 510(k) clearances |
| Aug 18, 2016 | NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow Class II · WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as exp | Device recalls |
| Jun 23, 2016 | NIO-PK160805 · FMI | 510(k) clearances |
| Aug 28, 2014 | NIO -INTRAOSSEOUS DEVICEK142086 · FMI | 510(k) clearances |
| Dec 22, 2006 | BONE INJECTION GUN (B.I.G.)K062940 · FMI | 510(k) clearances |
| Oct 11, 2002 | BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1STK022415 · FMI | 510(k) clearances |
| Nov 17, 1998 | BONE INJECTION GUN (B.I.G.) DEVICEK981853 · FMI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
