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"
745–768 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Dec 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
K013580 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 44d
Cleared Dec 12, 2001
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
K013423 · JWY
Dade Microscan, Inc.
Microbiology · 71d
Cleared Nov 26, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013075 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Nov 20, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013368 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 40d
Cleared Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
K011812 · NHC
Cook, Inc.
Neurology · 150d
Cleared Nov 07, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
K013195 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 43d
Cleared Nov 02, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012921 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Oct 31, 2001
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE...
K011761 · DYB
Arrow Intl., Inc.
Cardiovascular · 147d
Cleared Oct 30, 2001
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K012895 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Oct 26, 2001
BIOPATCH ANTIMICROBIAL DRESSING
K003229 · SEL
Integra Lifesciences Corp.
General & Plastic Surgery · 381d
Cleared Sep 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012565 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Sep 12, 2001
ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
K012116 · FRO
Acrymed, Inc.
General & Plastic Surgery · 68d
Cleared Aug 29, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012151 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Aug 22, 2001
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
K011941 · FRO
The Kendall Company
General & Plastic Surgery · 62d
Cleared Aug 22, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010418 · LTT
Dade Behring, Inc.
Microbiology · 191d
Cleared Aug 15, 2001
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
K011803 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 65d
Cleared Jul 27, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159 · LTT
Dade Microscan, Inc.
Microbiology · 191d
Cleared Jun 13, 2001
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
K011384 · JTN
Hardy Diagnostics
Microbiology · 37d
Cleared May 18, 2001
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · JTN
Hardy Diagnostics
Microbiology · 11d
Cleared Apr 26, 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · JTN
Hardy Diagnostics
Microbiology · 16d
Cleared Apr 24, 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116 · LTT
Pasco Laboratories, Inc.
Microbiology · 62d
Cleared Apr 24, 2001
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010537 · JTN
Oxoid , Ltd.
Microbiology · 60d
Cleared Apr 24, 2001
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010536 · JTN
Oxoid , Ltd.
Microbiology · 60d
Cleared Apr 24, 2001
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
K000442 · KKX
Medical Concepts Development, Inc.
General Hospital · 439d