Bloomington, IN, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DYB | Introducer, Catheter | Class II | Cardiovascular | 1 | 2024-03-25 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-12-07 | Class II | Ongoing | Z-0722-2024 | MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429 | — | The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead… |
| 2020-12-16 | Class II | Terminated | Z-0809-2021 | Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707 | — | A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from … |