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Thermo Fisher Scientific FDA Approvals
0 new drug approvals and 27 device clearances on file. Matched by name to TMO.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL510(k)Sep 25, 2025Microbiology |
| The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL510(k)Sep 5, 2025Microbiology |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL510(k)Aug 28, 2025Microbiology |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL510(k)Jun 30, 2025Microbiology |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.510(k)Jun 20, 2025Microbiology |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL510(k)May 22, 2025Microbiology |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL510(k)Apr 15, 2025Microbiology |
| The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL510(k)Feb 27, 2025Microbiology |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL510(k)Feb 10, 2025Microbiology |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL510(k)Feb 10, 2025Microbiology |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL510(k)Dec 19, 2024Microbiology |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL510(k)Dec 5, 2024Microbiology |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL510(k)Nov 26, 2024Microbiology |
| The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.510(k)Oct 9, 2024Microbiology |
| The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.510(k)Oct 1, 2024Microbiology |
| The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.510(k)May 16, 2024Microbiology |
| Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml510(k)Oct 31, 2023Microbiology |
| The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL510(k)Aug 31, 2023Microbiology |
| Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml510(k)Aug 30, 2023Microbiology |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL510(k)Aug 25, 2023Microbiology |
| Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)510(k)Jun 30, 2023Microbiology |
| Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)510(k)Mar 21, 2023Microbiology |
| Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL510(k)Mar 10, 2023Microbiology |
| The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml510(k)Jan 20, 2023Microbiology |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml510(k)Dec 20, 2021Microbiology |
| Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL510(k)Dec 15, 2021Microbiology |
| Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)510(k)Jul 23, 2021Microbiology |