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"
49–72 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Mar 28, 2025
PBC Separator with Selux AST System
K244044 · QZX
Selux Diagnostics, Inc.
Microbiology · 88d
Cleared Mar 14, 2025
VITEK COMPACT PRO
K234012 · LON
bioMerieux, Inc.
Microbiology · 451d
Cleared Mar 06, 2025
BD Phoenix™ Automated Microbiology System
K250344 · LON
Becton, Dickinson and Company
Microbiology · 28d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K243201 · JWY
Thermo Fisher Scientific
Microbiology · 132d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242905 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Jan 30, 2025
MTS Ceftobiprole 0.002-32 µg/mL
K243202 · JWY
Liofilchem S. R. L.
Microbiology · 121d
Cleared Dec 19, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K243169 · JWY
Thermo Fisher Scientific
Microbiology · 80d
Cleared Dec 05, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242653 · JWY
Thermo Fisher Scientific
Microbiology · 92d
Cleared Nov 26, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242657 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Oct 23, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K241324 · SAN
Affinity Biosensors, LLC
Microbiology · 166d
Cleared Oct 09, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242021 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 07, 2024
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription...
K240485 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 230d
Cleared Oct 01, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K241967 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Sep 05, 2024
ProGear® Surgical Mask with Oxafence®, Model AV82030
K231741 · OUK
Prestige Ameritech
General Hospital · 449d
Cleared Jul 19, 2024
coactiv+™ Antimicrobial Wound Gel
K241809 · FRO
Kane Biotech, Inc.
General & Plastic Surgery · 28d
Cleared Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
K241060 · JTN
Hardy Diagnostics
Microbiology · 91d
Cleared Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K230675 · SAN
Specific Diagnostics, LLC
Microbiology · 468d
Cleared Jun 18, 2024
Irrisept Antimicrobial Wound Lavage
K240552 · FRO
Irrimax Corporation
General & Plastic Surgery · 111d
Cleared Jun 06, 2024
Wellead® Latex Foley Catheter
K233094 · MJC
Well Lead Medical (Hainan) Co., Ltd.
Gastroenterology & Urology · 254d
Cleared May 31, 2024
Puracyn® Plus Antimicrobial Irrigation Solution
K232080 · FRO
Innovacyn, Inc.
General & Plastic Surgery · 323d
Cleared May 16, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K240445 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared Apr 26, 2024
ASTar BC G- Kit and ASTar Instrument
K221688 · SAN
Q-Linea AB
Microbiology · 686d
Cleared Apr 02, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
K211815 · SAN
Affinity Biosensors
Microbiology · 1026d
Cleared Mar 26, 2024
PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound...
K233151 · FRO
Medline Industries, LP
General & Plastic Surgery · 181d