Carefusion 209, Inc.
Medical device manufacturer in Middleton, WI.
5510(k) clearances
0PMA approvals
4recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K120979 | Carefusion Nicolet EdxGWF · Special | 04/25/2012SE |
| K112052 | Carefusion Nicolet EdxGWF · Traditional | 03/15/2012SE |
| K112034 | Teca Elite Disposable Concentric NeedlesIKT · Special | 08/12/2011SE |
| K111131 | Teca (TM) Elite Disposable Monopolar NeedlesIKT · Special | 06/17/2011SE |
| K103140 | Nicolet Wireless EEGGWL · Traditional | 04/08/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0737-2012 | NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use:…Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list… | 12/16/2011Terminated |
| Z-0801-2012 | Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800…CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control… | 10/05/2011Terminated |
| Z-0800-2012 | Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage:…CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control… | 10/05/2011Terminated |
| Z-0799-2012 | NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part…CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control… | 10/05/2011Terminated |