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"
1–24 of 80
Search insights Median review: 92d Cleared: 99% Top manufacturer: Thermo Fisher Scientific Lead specialty: Microbiology
Cleared Oct 23, 2026
B·R·A·H·M·S MR-proADM KRYPTOR
K260302 · SJQ
B·R·A·H·M·S GmbH (part of Thermo...
Microbiology · 266d
Cleared Jul 24, 2026
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
K261781 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 56d
Cleared Dec 05, 2025
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
K251337 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 219d
Cleared Sep 25, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252062 · JWY
Thermo Fisher Scientific
Microbiology · 86d
Cleared Sep 05, 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K250575 · JWY
Thermo Fisher Scientific
Microbiology · 191d
Cleared Aug 28, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252014 · JWY
Thermo Fisher Scientific
Microbiology · 62d
Cleared Jun 30, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K250990 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared Jun 20, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242843 · JWY
Thermo Fisher Scientific
Microbiology · 273d
Cleared Jun 12, 2025
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
K250789 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 90d
Cleared May 22, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242659 · JWY
Thermo Fisher Scientific
Microbiology · 260d
Cleared Apr 15, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242658 · JWY
Thermo Fisher Scientific
Microbiology · 223d
Cleared Feb 27, 2025
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution...
K243738 · NGZ
Thermo Fisher Scientific
Microbiology · 85d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K243201 · JWY
Thermo Fisher Scientific
Microbiology · 132d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242905 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Dec 19, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K243169 · JWY
Thermo Fisher Scientific
Microbiology · 80d
Cleared Dec 05, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242653 · JWY
Thermo Fisher Scientific
Microbiology · 92d
Cleared Nov 26, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242657 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Oct 09, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242021 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 01, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K241967 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared May 16, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K240445 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared Mar 22, 2024
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
K231806 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 276d
Cleared Nov 17, 2023
Alinity c Tricyclic Antidepressants Reagent Kit
K231020 · LFH
Microgenics Corporation
Toxicology · 221d
Cleared Oct 31, 2023
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or...
K232310 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 06, 2023
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
K232276 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 67d