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"
73–96 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Mar 22, 2024
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
K231806 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 276d
Cleared Mar 15, 2024
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
K233986 · LON
Becton, Dickinson and Company
Microbiology · 88d
Cleared Mar 11, 2024
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
K234000 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Feb 15, 2024
PBC Separator with Selux AST System
K223493 · QZX
Selux Diagnostics, Inc.
Microbiology · 451d
Cleared Feb 08, 2024
eQUANT System
K231536 · QZX
Avails Medical, Inc.
Microbiology · 254d
Cleared Dec 27, 2023
Colibrí
K232756 · LON
Copan Wasp Srl
Microbiology · 110d
Cleared Oct 31, 2023
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or...
K232310 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 26, 2023
Antimicrobial Gelling Fiber Dressing with PHMB
K213473 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 728d
Cleared Oct 25, 2023
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · KKX
Avery Dennison Medical , Ltd.
General Hospital · 231d
Cleared Oct 23, 2023
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2...
K232201 · LON
bioMerieux, Inc.
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
Cleared Oct 05, 2023
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
K232395 · JWY
Biom?rieux
Microbiology · 57d
Cleared Aug 30, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K231988 · JWY
Thermo Fisher Scientific
Microbiology · 56d
Cleared Aug 25, 2023
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K231994 · JWY
Thermo Fisher Scientific
Microbiology · 51d
Cleared Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite...
K223526 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 268d
Cleared Jul 06, 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
K231568 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Jul 05, 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP...
K230864 · LON
bioMerieux, Inc.
Microbiology · 98d
Cleared Jun 30, 2023
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or...
K230935 · JWY
Thermo Fisher Scientific
Microbiology · 88d
Cleared Jun 26, 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
K222378 · LON
bioMerieux, Inc.
Microbiology · 325d
Cleared Jun 07, 2023
BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
K230651 · JTN
Becton, Dickinson and Company
Microbiology · 90d
Cleared Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
K230827 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared May 24, 2023
coactiv+™ Antimicrobial Wound Gel
K223259 · FRO
Kane Biotech, Inc.
General & Plastic Surgery · 212d
Cleared May 18, 2023
ComASP Cefiderocol 0.008-128
K230479 · JWY
Liofilchem S. R. L.
Microbiology · 85d
Cleared Apr 19, 2023
Selux AST System
K211748 · LON
Selux Diagnostics, Inc.
Microbiology · 681d