Stihler Electronic GmbH
Medical device manufacturer in Leinfelden-Echterdingen, DE.
7510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | 07/08/2026SE |
| K202197 | Astopad Patient Warming SystemDWJ · Traditional | 09/04/2020SE |
| K082758 | Prismaflo IIKOC · Special | 12/19/2008SE |
| K082765 | Astoflo PlusLGZ · Traditional | 12/18/2008SE |
| K020103 | PrismafloKOC · Abbreviated | 07/24/2002SE |
| K991159 | Prismatherm II, AstolineBSB · Abbreviated | 09/03/1999SE |
| K991160 | Astotherm Plus, Astotubes, AstolineBSB · Abbreviated | 09/02/1999SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0761-2019 Class II | Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618…PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a… | 09/06/2018Terminated |
| Z-0760-2019 Class II | Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31…PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a… | 09/06/2018Terminated |
| Z-0759-2019 Class II | Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33…PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a… | 09/06/2018Terminated |