Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Stihler Electronic and its 1 subsidiaries with 8 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Jul 8, 2026: ThermAffyx(TM) Patient Safety System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Stihler Electronic and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 8, 2026 | ThermAffyx(TM) Patient Safety SystemK260278 · DWJ | 510(k) clearances |
| Sep 4, 2020 | Astopad Patient Warming SystemK202197 · DWJ | 510(k) clearances |
| Sep 6, 2018 | Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer isClass II · PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Hea | Device recalls |
| Sep 6, 2018 | Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is uClass II · PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Hea | Device recalls |
| Sep 6, 2018 | Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer iClass II · PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Hea | Device recalls |
| Dec 19, 2008 | PRISMAFLO IIK082758 · KOC | 510(k) clearances |
| Dec 18, 2008 | ASTOFLO PLUSK082765 · LGZ | 510(k) clearances |
| Jul 24, 2002 | PRISMAFLOK020103 · KOC | 510(k) clearances |
| Sep 3, 1999 | PRISMATHERM II, ASTOLINEK991159 · BSB | 510(k) clearances |
| Sep 2, 1999 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINEK991160 · BSB | 510(k) clearances |
| Aug 25, 1988 | STIHLER ASTOTHERM IFT 200, IFT 220K882361 · LGZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built