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"
217–240 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Dec 19, 2017
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
K172944 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Dec 15, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam...
K172337 · LTT
Beckman Coulter, Inc.
Microbiology · 135d
Cleared Dec 08, 2017
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
K172731 · LON
bioMerieux, Inc.
Microbiology · 88d
Cleared Dec 07, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 –...
K172912 · LTT
Beckman Coulter, Inc.
Microbiology · 73d
Cleared Dec 01, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K173209 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Dec 01, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam...
K172255 · LTT
Beckman Coulter, Inc.
Microbiology · 128d
Cleared Dec 01, 2017
Alevicyn SG Antimicrobial Gel
K171935 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 156d
Cleared Nov 21, 2017
Microcyn Antimicrobial Skin and Wound Cleanser
K172622 · FRO
Sonoma Pharmaceuticals
General & Plastic Surgery · 81d
Cleared Nov 21, 2017
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial...
K170754 · FRO
3M Company, 3M Healthcare
General & Plastic Surgery · 253d
Cleared Nov 15, 2017
Microcyn Plus Antimicrobial Wound Care Solution
K172851 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 56d
Cleared Oct 23, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
K172542 · JWY
Liofilchem S. R. L.
Microbiology · 61d
Cleared Oct 13, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K172454 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
K172621 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Sep 27, 2017
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
K172109 · JWY
Liofilchem S. R. L.
Microbiology · 76d
Cleared Sep 15, 2017
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
K172150 · JWY
bioMerieux, Inc.
Microbiology · 60d
Cleared Aug 30, 2017
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC...
K172274 · JWY
Thermo Fisher Scientific
Microbiology · 33d
Cleared Aug 01, 2017
HardyDisk AST Delafloxacin 5 µg (DLX5)
K171975 · JTN
Hardy Diagnostics
Microbiology · 32d
Cleared Aug 01, 2017
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
K171906 · JWY
Liofilchem S. R. L.
Microbiology · 36d
Cleared Aug 01, 2017
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K171870 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Jul 26, 2017
Hydrocleanse Antimicrobial Skin and Wound Care Solution
K171727 · FRO
Sonoma Pharmaceuticals
General & Plastic Surgery · 44d
Cleared Jul 25, 2017
PHMB Antimicrobial Foam Wound Dressing
K163062 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 265d
Cleared Jul 17, 2017
BD ChloraShield IV Dressing with CHG Antimicrobial
K170407 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 157d
Cleared Jun 21, 2017
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
K162737 · LON
bioMerieux, Inc.
Microbiology · 264d
Cleared Jun 07, 2017
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
K170772 · JWY
Liofilchem S. R. L.
Microbiology · 85d