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"
481–504 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Nov 15, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML
K062944 · LON
Becton, Dickinson & CO
Microbiology · 48d
Cleared Nov 09, 2006
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062839 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 49d
Cleared Nov 01, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062816 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 42d
Cleared Oct 26, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062783 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 24, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 -...
K062687 · LON
Becton, Dickinson & CO
Microbiology · 46d
Cleared Oct 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062722 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 20, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
K062705 · LON
Dade Behring, Inc.
Microbiology · 39d
Cleared Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
K062773 · LTT
Dade Behring, Inc.
Microbiology · 25d
Cleared Oct 13, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062681 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 35d
Cleared Oct 10, 2006
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
K062777 · LTT
Dade Behring, Inc.
Microbiology · 22d
Cleared Oct 06, 2006
ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
K061232 · FRO
Acrymed, Inc.
General & Plastic Surgery · 157d
Cleared Oct 05, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML
K062680 · LON
Becton, Dickinson & CO
Microbiology · 27d
Cleared Sep 13, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML
K062207 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Sep 11, 2006
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062022 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 56d
Cleared Sep 08, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML
K062206 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Aug 31, 2006
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K062190 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 31d
Cleared Aug 23, 2006
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
K062245 · JTN
Hardy Diagnostics
Microbiology · 21d
Cleared Aug 18, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP)...
K061869 · LON
Becton, Dickinson & CO
Microbiology · 46d
Cleared Aug 10, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML
K061867 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Jul 28, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP)...
K061673 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jul 21, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061687 · JWY
Dade Behring, Inc.
Microbiology · 36d
Cleared Jul 18, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061536 · JWY
Dade Behring, Inc.
Microbiology · 46d
Cleared Jul 14, 2006
TYRX ANTIMICROBIAL MESH
K053656 · FTL
Tyrx Pharma, Inc.
General & Plastic Surgery · 196d
Cleared Jul 03, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN)...
K061327 · LON
Becton, Dickinson & CO
Microbiology · 52d