Waismed Ltd.
Rosh Haayin Central, IL
Waismed Ltd. appears in FDA device records in Rosh Haayin Central, IL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 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 7 510(k) clearances for Waismed Ltd. between 1998 and 2021. The busiest year on record is 1998, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2002 | 1 |
| 2006 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211968 | NIO+ Adult | FMI | Substantially Equivalent | |
| K190538 | NIO-I | FMI | Substantially Equivalent | |
| K160805 | NIO-P | FMI | Substantially Equivalent | |
| K142086 | NIO -INTRAOSSEOUS DEVICE | FMI | Substantially Equivalent | |
| K062940 | BONE INJECTION GUN (B.I.G.) | FMI | Substantially Equivalent | |
| K022415 | BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST | FMI | Substantially Equivalent | |
| K981853 | BONE INJECTION GUN (B.I.G.) DEVICE | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616791 | 3001316486 | Waismed Ltd. | 10 Amal St., Rosh Haayin Central 4809234 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2119-2025 | 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 device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. | Class II | Open, Classified | |
| Z-2118-2025 | Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. | Class II | Open, Classified | |
| Z-2680-2016 | 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 of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age. | WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle was released spontaneously. NIO-A and the NIO-P models have the same activation mechanism. However, none of the affected lots of the NIO-A are distributed in the US, and thus the company is only recalling a single lot of NIO-P in the US. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain