Company ยท US
Stihler Electronic GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (1 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2026 | K260278 | ThermAffyx(TM) Patient Safety System Stihler Electronic GmbH, DE | DWJ |
| Sep 4, 2020 | K202197 | Astopad Patient Warming System Stihler Electronic GmbH, DE | DWJ |
| Dec 19, 2008 | K082758 | PRISMAFLO II Stihler Electronic GmbH | KOC |
| Dec 18, 2008 | K082765 | ASTOFLO PLUS Stihler Electronic GmbH | LGZ |
| Jul 24, 2002 | K020103 | PRISMAFLO Stihler Electronic GmbH | KOC |
| Sep 3, 1999 | K991159 | PRISMATHERM II, ASTOLINE Stihler Electronic GmbH | BSB |
| Sep 2, 1999 | K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE Stihler Electronic GmbH | BSB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2018 | Stihler Electronic Gmbh Heating Profile PRISMAFLO II blood return warmer for
Prismaflex
Product Code: PF2-WP2618
Product Usage:
The PRISMAFLO IIS warmer is used for warming return blood flow. Terminated |
KOC | K082758 |
| Sep 6, 2018 | Stihler Electronic Gmbh Heating Profile PRISMAFLO II S blood return warmer for
Prismaflex
Product Code: PF2-WP31
Product Usage:
The PRISMAFLO IIS warmer is used for warming return blood flow. Terminated |
KOC | K082758 |
| Sep 6, 2018 | Stihler Electronic Gmbh Heating Profile PRISMAFLO II S blood return warmer for Prismaflex
Product Code: PF2-WP33
Product Usage:
The PRISMAFLO IIS warmer is used for warming return blood flow. Terminated |
KOC | K082758 |