Stihler Electronic Gmbh
FDA Regulatory Profile
Stihler Electronic Gmbh appears in FDA public data with 3 recalls, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0759-2019, Class II) was initiated on September 6, 2018. Its most recent 510(k) clearance was granted on July 8, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0759-2019 | Class II | Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Produc | September 6, 2018 |
| Z-0761-2019 | Class II | Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Pro | September 6, 2018 |
| Z-0760-2019 | Class II | Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Prod | September 6, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260278 | ThermAffyx(TM) Patient Safety System | July 8, 2026 |
| K202197 | Astopad Patient Warming System | September 4, 2020 |
| K082758 | PRISMAFLO II | December 19, 2008 |
| K082765 | ASTOFLO PLUS | December 18, 2008 |
| K020103 | PRISMAFLO | July 24, 2002 |
| K991159 | PRISMATHERM II, ASTOLINE | September 3, 1999 |
| K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | September 2, 1999 |