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"
145–168 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Mar 20, 2020
MTS Omadacycline 0.002 - 32 ug/mL
K200180 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Mar 18, 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004...
K193536 · LTT
Beckman Coulter, Inc.
Microbiology · 89d
Cleared Mar 13, 2020
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
K193572 · LON
bioMerieux, Inc.
Microbiology · 81d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K193538 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 03, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx)...
K193358 · LTT
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Feb 14, 2020
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
K193567 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Feb 07, 2020
Rochal Antimicrobial Wound Gel
K192527 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 147d
Cleared Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
K193504 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Jan 08, 2020
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K193024 · JWY
Thermo Fisher Scientific
Microbiology · 70d
Not Cleared Dec 05, 2019
cobas vivoDx MRSA
DEN190016 · QIV
Roche Molecular Systems, Inc.
Microbiology · 261d
Cleared Nov 29, 2019
Innonix Antiviral Child's Face Mask
K192105 · OUK
Innonix Technologies Limited
General Hospital · 116d
Cleared Nov 26, 2019
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
K192738 · JWY
Biomerieux S.A.
Microbiology · 60d
Cleared Nov 14, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)...
K192355 · JWY
Beckman Coulter, Inc.
Microbiology · 77d
Cleared Nov 06, 2019
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin...
K192729 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345 · JWY
Liofilchem S. R. L.
Microbiology · 63d
Cleared Oct 31, 2019
Vitek Densichek
K192110 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K192250 · JWY
Thermo Fisher Scientific
Microbiology · 58d
Cleared Oct 11, 2019
Protego Antimicrobial Wound Dressing
K183681 · FRO
Global Health Solutions (Dba Turn...
General & Plastic Surgery · 287d
Cleared Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
K192050 · JWY
Biomerieux S.A.
Microbiology · 58d
Cleared Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · JTN
Hardy Diagnostics
Microbiology · 23d
Cleared Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
K191908 · JWY
Liofilchem S. R. L.
Microbiology · 50d
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613 · POC
Check-Points Health B.V.
Microbiology · 171d
Cleared Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809 · JWY
Liofilchem S. R. L.
Microbiology · 49d
Cleared Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953 · JWY
Biomerieux S.A.
Microbiology · 31d