Thermo Fisher Scientific
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 65
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1202-2021 | Class II | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 | February 1, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution rang | September 25, 2025 |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the | September 5, 2025 |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution rang | August 28, 2025 |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution | June 30, 2025 |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Sus | June 20, 2025 |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution ra | May 22, 2025 |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution | April 15, 2025 |
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/m | February 27, 2025 |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Sus | February 10, 2025 |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Sus | February 10, 2025 |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution | December 19, 2024 |
| K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution ran | December 5, 2024 |
| K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution ra | November 26, 2024 |
| K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint S | October 9, 2024 |
| K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint S | October 1, 2024 |
| K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint S | May 16, 2024 |
| K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibili | October 31, 2023 |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | August 31, 2023 |
| K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibili | August 30, 2023 |
| K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilu | August 25, 2023 |