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"
121–144 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Dec 20, 2021
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K203741 · JWY
Thermo Fisher Scientific
Microbiology · 363d
Cleared Nov 12, 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
K210757 · JWY
Biomerieux S.A.
Microbiology · 242d
Cleared Oct 28, 2021
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287 · LON
bioMerieux, Inc.
Microbiology · 268d
Cleared Oct 27, 2021
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
K210873 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 217d
Cleared Oct 20, 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · JWY
Liofilchem S. R. L.
Microbiology · 141d
Cleared Sep 14, 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · LON
bioMerieux, Inc.
Microbiology · 389d
Cleared Aug 30, 2021
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
K211630 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared Jul 30, 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 224d
Cleared Jul 30, 2021
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · KKX
Avery Dennison Belgie Bvba
General Hospital · 358d
Cleared Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or...
K202612 · JWY
Thermo Fisher Scientific
Microbiology · 317d
Cleared Jul 09, 2021
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
K201675 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Jun 14, 2021
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
K211136 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared May 28, 2021
Irrisept Antimicrobial Wound Lavage
K210536 · FQH
Irrimax Corporation
General & Plastic Surgery · 93d
Cleared May 18, 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423 · JWY
Beckman Coulter, Inc.
Microbiology · 266d
Cleared May 12, 2021
High Performance Antimicrobial Gelling Fiber with Silver
K210974 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 41d
Cleared Dec 04, 2020
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
K193508 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 352d
Cleared Nov 16, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64...
K202343 · LTT
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Sep 28, 2020
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
K193299 · LON
bioMerieux, Inc.
Microbiology · 306d
Cleared Aug 30, 2020
LabPro Data Management System
K201405 · LON
Beckman Coulter, Inc.
Microbiology · 94d
Cleared Jun 29, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32...
K201423 · LTT
Beckman Coulter, Inc.
Microbiology · 31d
Cleared Jun 25, 2020
FiteBac Antimicrobial Cavity Cleanser
K200614 · LBH
Largent Health, LLC
Dental · 108d
Cleared May 07, 2020
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
K200512 · JWY
Biom?rieux SA
Microbiology · 66d
Cleared Apr 28, 2020
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
K200590 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Apr 06, 2020
MTS Lefamulin 0.016- 256 µg/mL
K200308 · JWY
Liofilchem S. R. 1.
Microbiology · 60d