Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

80 results for "Thermo Fisher Scientific"
25–48 of 80
Search insights Median review: 92d Cleared: 99% Top manufacturer: Thermo Fisher Scientific Lead specialty: Microbiology
Cleared Aug 31, 2023
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution...
K231433 · NGZ
Thermo Fisher Scientific
Microbiology · 106d
Cleared Aug 30, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K231988 · JWY
Thermo Fisher Scientific
Microbiology · 56d
Cleared Aug 25, 2023
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K231994 · JWY
Thermo Fisher Scientific
Microbiology · 51d
Cleared Jun 30, 2023
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or...
K230935 · JWY
Thermo Fisher Scientific
Microbiology · 88d
Not Cleared May 18, 2023
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
DEN220027 · QWH
Brahms GmbH, Part of Thermo Fisher...
Chemistry · 381d
Cleared Mar 21, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K223844 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Mar 10, 2023
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution...
K221198 · NGZ
Thermo Fisher Scientific
Microbiology · 318d
Cleared Jan 20, 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the...
K221899 · NGZ
Thermo Fisher Scientific
Microbiology · 204d
Cleared Sep 15, 2022
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
K203336 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 672d
Cleared Dec 20, 2021
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K203741 · JWY
Thermo Fisher Scientific
Microbiology · 363d
Cleared Dec 15, 2021
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution...
K211539 · NGZ
Thermo Fisher Scientific
Microbiology · 211d
Cleared Oct 27, 2021
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
K210873 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 217d
Cleared Jul 30, 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 224d
Cleared Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or...
K202612 · JWY
Thermo Fisher Scientific
Microbiology · 317d
Cleared Dec 04, 2020
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
K193508 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 352d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K193538 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Jan 08, 2020
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K193024 · JWY
Thermo Fisher Scientific
Microbiology · 70d
Cleared Nov 06, 2019
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin...
K192729 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
K191918 · LRG
Thermo Fisher Scientific
Microbiology · 111d
Cleared Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
K191914 · LRG
Thermo Fisher Scientific
Microbiology · 112d
Cleared Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K192250 · JWY
Thermo Fisher Scientific
Microbiology · 58d
Cleared Feb 15, 2019
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K183324 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K183033 · JWY
Thermo Fisher Scientific
Microbiology · 64d
Cleared Nov 30, 2018
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K182797 · JWY
Thermo Fisher Scientific
Microbiology · 60d