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"
169–192 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
K191766 · LON
bioMerieux, Inc.
Microbiology · 35d
Cleared Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
K191931 · JTN
Hardy Diagnostics
Microbiology · 12d
Cleared Jul 01, 2019
BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
K190905 · LON
Becton, Dickinson and Company
Microbiology · 84d
Cleared Jun 06, 2019
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
K190616 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared May 29, 2019
MTS Doxycycline 0.016 - 256 µg/mL
K190914 · JWY
Liofilchem S. R. L.
Microbiology · 51d
Cleared May 01, 2019
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
K190154 · JWY
Biomerieux S.A.
Microbiology · 91d
Cleared Apr 29, 2019
HardyCHROM CRE
K190553 · JSO
Hardy Diagnostics
Microbiology · 55d
Cleared Apr 18, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)...
K190109 · JWY
Beckman Coulter, Inc.
Microbiology · 85d
Cleared Mar 22, 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · JWY
Liofilchem S. R. L.
Microbiology · 43d
Cleared Mar 19, 2019
MTS Ciprofloxacin 0.002 - 32 µg/mL
K183527 · JWY
Liofilchem S. R. L.
Microbiology · 90d
Cleared Mar 12, 2019
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
K183524 · LON
bioMerieux, Inc.
Microbiology · 83d
Cleared Mar 07, 2019
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
K183551 · LON
bioMerieux, Inc.
Microbiology · 77d
Cleared Feb 26, 2019
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
K183360 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Feb 20, 2019
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)
K183415 · LON
bioMerieux, Inc.
Microbiology · 72d
Cleared Feb 15, 2019
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K183324 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Feb 14, 2019
Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing,...
K181315 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 272d
Cleared Feb 12, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam...
K183127 · LTT
Beckman Coulter, Inc.
Microbiology · 91d
Cleared Jan 18, 2019
HardyDisk AST Omadacycline 30µg (OMC30)
K183298 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Jan 11, 2019
MTS Tetracycline 0.016 - 256 ug/mL
K183140 · JWY
Liofilchem S. R. L.
Microbiology · 59d
Cleared Jan 11, 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
K183031 · JWY
Biomerieux S.A.
Microbiology · 71d
Cleared Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K183033 · JWY
Thermo Fisher Scientific
Microbiology · 64d
Cleared Jan 03, 2019
Cufitec Surgical Mask
K182766 · OUK
Nbc Meshtec, Inc.
General Hospital · 97d
Cleared Dec 20, 2018
MTS Levofloxacin 0.002 - 32 µg/mL
K183115 · JWY
Liofilchem S. R. L.
Microbiology · 41d
Cleared Dec 14, 2018
MTS Omadacycline 0.002-32 µg/mL
K182922 · JWY
Liofilchem S. R. L.
Microbiology · 56d