Chrysalis Intelligence · Sponsors · Waismed, Ltd.

Waismed, Ltd.

Rosh Ha'Ayin, IL · 1 510(k) clearances · 2 recalls

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Total clearances
1
2021-07-22 → 2021-07-22
Last 12 months
0
Product codes
1
Most recent
2021-07-22
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FMI Needle, Hypodermic, Single Lumen Class II General Hospital 1 2021-07-22
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2025-06-05
DateSeverityStatusRecall # ProductCodeReason
2025-06-05 Class II Ongoing Z-2119-2025 Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A P… — Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
2025-06-05 Class II Ongoing Z-2118-2025 Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A … — Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-07-22 K211968 NIO+ Adult FMI Class II General Hospital
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence