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"
1–24 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Jul 24, 2026
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
K261781 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 56d
Cleared Jul 23, 2026
Gepotidacin GEP 10 µg
K261853 · JTN
Liofilchem, Inc.
Microbiology · 50d
Cleared Jul 08, 2026
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K260160 · SAN
bioMerieux, Inc.
Microbiology · 169d
Cleared Jul 02, 2026
Xpert Carba-R
K261867 · POC
Cepheid
Microbiology · 28d
Cleared Jun 26, 2026
PhAST instrument and PhAST Blood Culture Gram-negative Panel
K253316 · SAN
Phast Corp.
Microbiology · 269d
Cleared Jun 24, 2026
SilverCeuticals® Antimicrobial Wound Gel
K251929 · FRO
Silverceuticals, Inc.
General & Plastic Surgery · 366d
Cleared May 11, 2026
HardyDisk AST Gepotidacin 10µg (GEP10)
K260842 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Apr 21, 2026
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
K260447 · JWY
Biom?rieux SA
Microbiology · 69d
Cleared Apr 17, 2026
MTS Gepotidacin 0.016-256 µg/mL
K260696 · JWY
Liofilchem S. R. L.
Microbiology · 45d
Cleared Apr 15, 2026
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
K260282 · LON
bioMerieux, Inc.
Microbiology · 76d
Cleared Apr 15, 2026
ASTar BC G- Kit
K253573 · SAN
Q-Linea AB
Microbiology · 149d
Cleared Mar 26, 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
K260281 · LON
BIOMERIEUX
Microbiology · 56d
Cleared Mar 25, 2026
MiraChlor Antimicrobial Wound Solution
K252023 · FRO
Letus Corporation
General & Plastic Surgery · 268d
Cleared Mar 11, 2026
LUOFUCON® Antimicrobial Wound Gel
K252028 · FRO
Huizhou Foryou Medical Co., Ltd.
General & Plastic Surgery · 254d
Cleared Feb 25, 2026
BD Surgiphor™ Antimicrobial Irrigation System (910110)
K253996 · FQH
Becton, Dickinson and Company (BD)
General & Plastic Surgery · 75d
Cleared Feb 20, 2026
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
K253445 · FQH
Bd
General & Plastic Surgery · 141d
Not Cleared Feb 06, 2026
Amferia Wound Dressing
DEN250006 · SHA
Amferia AB
General & Plastic Surgery · 340d
Cleared Jan 08, 2026
revyve® Antimicrobial Skin and Wound Cleanser
K252759 · FRO
Kane Biotech, Inc.
General & Plastic Surgery · 132d
Cleared Jan 05, 2026
Puracyn® Plus Antimicrobial Irrigation Solution
K251757 · FRO
Innovacyn, Inc.
General & Plastic Surgery · 210d
Cleared Dec 05, 2025
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
K251337 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 219d
Cleared Nov 20, 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
K253105 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Nov 07, 2025
MultiMatch Flow Chameleon AntiMicrobial Composite
K253513 · EBF
Premier Dental Products Company
Dental · 1d
Cleared Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K251875 · SAN
Affinity Biosensors, LLC
Microbiology · 131d
Cleared Oct 10, 2025
Tegaderm Post-Op Transparent Antimicrobial Dressing
K251866 · FRO
Solventum US, LLC
General & Plastic Surgery · 115d