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"
601–624 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
K033362 · LON
Becton, Dickinson & CO
Microbiology · 171d
Cleared Apr 07, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN...
K031601 · LON
Dade Behring, Inc.
Microbiology · 317d
Cleared Mar 19, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K040099 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Mar 11, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
K040106 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Mar 01, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
K032675 · LON
Becton, Dickinson & CO
Microbiology · 185d
Cleared Feb 27, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE
K040006 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE...
K033940 · LTT
Dade Behring, Inc.
Microbiology · 68d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · JWY
Dade Behring, Inc.
Microbiology · 161d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT...
K033889 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
K033784 · LON
Becton, Dickinson & CO
Microbiology · 61d
Cleared Feb 03, 2004
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 88d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64...
K033560 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE
K033557 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Dec 19, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64...
K033558 · LON
Becton, Dickinson & CO
Microbiology · 37d
Cleared Nov 26, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K033482 · LON
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 26, 2003
MYCOPLASMA IGG
K033064 · LON
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 18, 2003
PASCO MIC AND MIC/ID PANELS
K033119 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Nov 12, 2003
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
K032861 · LON
bioMerieux, Inc.
Microbiology · 61d
Cleared Nov 04, 2003
VITEK 2 GRAM NEGATIVE GATIFLOXACIN
K032788 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE LINEZOLID
K032766 · LON
bioMerieux, Inc.
Microbiology · 56d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
K032738 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Oct 31, 2003
VITEK GRAM NEGATIVE GATIFLOXACIN
K032711 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared Oct 30, 2003
STERISIL ANTIMICROBIAL TUBING AND BOTTLE
K031681 · EIA
Sterisil
Dental · 153d