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"
25–48 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Oct 02, 2025
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
K252114 · JWY
Liofilchem S. R. L.
Microbiology · 87d
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 Aug 21, 2025
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Aug 20, 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
K251580 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Aug 20, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64...
K243804 · LTT
Beckman Coulter, Inc.
Microbiology · 252d
Cleared Aug 15, 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32...
K250036 · LTT
Beckman Coulter, Inc.
Microbiology · 219d
Cleared Aug 12, 2025
Sulopenem SPM 2 µg
K251879 · JTN
Liofilchem
Microbiology · 55d
Cleared Aug 08, 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
K251713 · LON
Becton, Dickinson and Company
Microbiology · 66d
Cleared Jul 18, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64...
K250084 · LTT
Beckman Coulter, Inc.
Microbiology · 186d
Cleared Jun 30, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K250990 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared Jun 26, 2025
HardyDisk AST Gepotidacin 10µg (GEP10)
K250956 · JTN
Hardy Diagnostics
Microbiology · 87d
Cleared Jun 23, 2025
Ceftobiprole BPR 5 µg Disc
K250885 · JTN
Liofilchem, Inc.
Microbiology · 90d
Cleared Jun 20, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242843 · JWY
Thermo Fisher Scientific
Microbiology · 273d
Cleared Jun 12, 2025
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
K250856 · JWY
Biom?rieux
Microbiology · 83d
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 May 19, 2025
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4...
K250447 · LON
Becton, Dickinson and Company
Microbiology · 90d
Cleared May 15, 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
K250454 · JTN
Hardy Diagnostics
Microbiology · 86d
Cleared May 02, 2025
Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
K243457 · FRO
Seriously Clean, Ltd.
General & Plastic Surgery · 176d
Cleared Apr 30, 2025
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
K250274 · JWY
Biomerieux S.A.
Microbiology · 90d
Cleared Apr 21, 2025
Spectricept Skin and Wound Cleanser
K243875 · FRO
Spectrum Antimicrobials, Inc.
General & Plastic Surgery · 125d
Cleared Apr 15, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242658 · JWY
Thermo Fisher Scientific
Microbiology · 223d