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"
97–120 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Apr 05, 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
K223310 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 159d
Cleared Mar 21, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K223844 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Mar 09, 2023
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN...
K222430 · LON
Biomerieux Sa, Inc.
Microbiology · 210d
Cleared Feb 16, 2023
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)
K223478 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Feb 09, 2023
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
K222073 · LON
bioMerieux, Inc.
Microbiology · 210d
Cleared Feb 03, 2023
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
K223481 · LON
bioMerieux, Inc.
Microbiology · 77d
Cleared Jan 27, 2023
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP...
K220803 · LON
bioMerieux, Inc.
Microbiology · 315d
Cleared Jan 18, 2023
Selux AST System
K211759 · LON
Selux Diagnostics, Inc.
Microbiology · 590d
Cleared Jan 13, 2023
Antimicrobial gauze sponge dressing
K221755 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 211d
Cleared Jan 13, 2023
Spectricept Skin and Wound Cleanser
K213514 · FRO
Spectrum Antimicrobials, Inc....
General & Plastic Surgery · 437d
Cleared Dec 21, 2022
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
K221826 · JTN
Becton, Dickinson and Company
Microbiology · 181d
Cleared Oct 14, 2022
BD Surgiphor™ Antimicrobial Irrigation System
K221504 · FQH
Bd
General & Plastic Surgery · 144d
Cleared Oct 13, 2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805 · LON
bioMerieux, Inc.
Microbiology · 209d
Cleared Oct 05, 2022
Colibrí System
K220546 · LON
Copan Wasp Srl
Microbiology · 222d
Cleared Sep 22, 2022
Irrisept Antimicrobial Wound Lavage
K222804 · FQH
Irrimax Corporation
General & Plastic Surgery · 6d
Cleared Sep 15, 2022
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
K203336 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 672d
Cleared Aug 08, 2022
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
K212243 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Jul 12, 2022
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS...
K213899 · LON
bioMerieux, Inc.
Microbiology · 210d
Cleared Jun 03, 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
K213931 · LON
bioMerieux, Inc.
Microbiology · 169d
Cleared Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
K211123 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 372d
Cleared Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
K214023 · LON
bioMerieux, Inc.
Microbiology · 113d
Cleared Mar 23, 2022
BD Surgiphor Antimicrobial Irrigation System
K213616 · FQH
Becton, Dickinson and Company
General & Plastic Surgery · 128d
Cleared Feb 25, 2022
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole...
K213241 · LON
bioMerieux, Inc.
Microbiology · 148d
Cleared Feb 04, 2022
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
K212849 · LON
Biom?rieux, Inc.
Microbiology · 150d