FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,479 results for "antimicrobial"
193–216 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Dec 10, 2018
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
K181766 · LON
bioMerieux, Inc.
Microbiology · 160d
Cleared Nov 30, 2018
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K182797 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Nov 02, 2018
MTS Eravacycline 0.002 - 32 µg/mL
K182557 · JWY
Liofilchem S. R. L.
Microbiology · 46d
Cleared Sep 27, 2018
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
K181975 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 65d
Cleared Sep 26, 2018
HardyDisk AST Eravacycline 20µg (ERV20)
K182357 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Sep 21, 2018
BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
K181665 · LON
Becton, Dickinson and Company
Microbiology · 88d
Cleared Sep 13, 2018
MTS Penicillin 0.002- 32 µg/mL
K181889 · JWY
Liofilchem S. R. L.
Microbiology · 62d
Cleared Aug 17, 2018
Simple Science Antimicrobial Facial and Eyelid Cleanser
K181074 · FRO
Simple Science, LLC
General & Plastic Surgery · 115d
Cleared Aug 08, 2018
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in...
K181946 · JWY
Thermo Fisher Scientific
Microbiology · 19d
Cleared Jul 31, 2018
MTS Plazomicin 0.016-256 µg/mL
K181708 · JWY
Liofilchem S. R. L.
Microbiology · 33d
Cleared Jul 10, 2018
HardyDisk AST Plazomicin 30ug (PLZ30)
K181700 · JTN
Hardy Diagnostics
Microbiology · 13d
Cleared Jul 06, 2018
CHROMID CARBA agar (CARB)
K181092 · JSO
Biomerieux S.A.
Microbiology · 72d
Cleared Jul 03, 2018
ETEST Telavancin (TLA) (0.002-32 ug/mL)
K180936 · JWY
Biomerieux S.A.
Microbiology · 84d
Cleared May 25, 2018
ClearGuard HD Antimicrobial Barrier Cap
K180111 · PEH
Pursuit Vascular, Inc.
Gastroenterology & Urology · 129d
Cleared May 18, 2018
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
K180886 · JWY
Liofilchem S. R. L.
Microbiology · 44d
Cleared Apr 04, 2018
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
K180339 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Apr 02, 2018
Microcyn Antimicrobial Hydrogel
K173896 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 101d
Cleared Mar 15, 2018
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
K180330 · JWY
Liofilchem S. R. L.
Microbiology · 37d
Cleared Feb 28, 2018
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
K173817 · JWY
Liofilchem S. R. L.
Microbiology · 75d
Cleared Feb 09, 2018
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam...
K173523 · LON
Becton, Dickinson and Company
Microbiology · 87d
Cleared Jan 09, 2018
Xpert Carba-R
K173263 · POC
Cepheid
Microbiology · 90d
Cleared Jan 05, 2018
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam...
K173252 · LON
Becton, Dickinson and Company
Microbiology · 87d
Cleared Dec 28, 2017
MRSASelect II
K171061 · JSO
Bio-Rad
Microbiology · 262d
Cleared Dec 19, 2017
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
K173307 · JWY
Liofilchem S. R. L.
Microbiology · 62d