Company ยท US
Carefusion 209, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2012. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2012 | K120979 | CAREFUSION NICOLET EDX Carefusion 209, Inc. | GWF |
| Mar 15, 2012 | K112052 | CAREFUSION NICOLET EDX Carefusion 209, Inc. | GWF |
| Aug 12, 2011 | K112034 | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES Carefusion 209, Inc. | IKT |
| Jun 17, 2011 | K111131 | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES Carefusion 209, Inc. | IKT |
| Apr 8, 2011 | K103140 | NICOLET WIRELESS EEG Carefusion 209, Inc. | GWL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2012 | CareFusion 209 Inc. Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F.
Product Usage:
The SSU Amplifier is used with the Cortical Sti Terminated |
GYC | K072964 |
| Jan 26, 2012 | CareFusion 209 Inc. Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558
Product Usage:
The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping p Terminated |
GYC | K072964 |
| Jan 26, 2012 | CareFusion 209 Inc. NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600
Product Usage:
The SSU Amplifier is used with the Cortical Stimulator Control unit which is used Terminated |
GYC | K072964 |
| Jan 13, 2012 | CareFusion 209 Inc. NicVue Software version 2.9.2 and 3.0.1.
Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue softw Terminated |
OUG | None listed |