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"
385–408 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Nov 12, 2009
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
K092826 · FRO
American Biotech Labs
General & Plastic Surgery · 59d
Cleared Nov 09, 2009
DENSICHECK PLUS
K093224 · LON
bioMerieux, Inc.
Microbiology · 26d
Cleared Oct 23, 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
K092919 · LON
Siemens Healthcare Diagnostics
Microbiology · 30d
Cleared Oct 21, 2009
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
K091354 · FRO
Acrymed, Inc.
General & Plastic Surgery · 166d
Cleared Sep 11, 2009
DENSICHEK PLUS
K083536 · LON
bioMerieux, Inc.
Microbiology · 287d
Cleared Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · LON
bioMerieux, Inc.
Microbiology · 50d
Cleared Aug 07, 2009
DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
K090791 · FRO
Century Pharmaceuticals, Inc.
General & Plastic Surgery · 136d
Cleared Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · LTT
Siemens Healthcare Diagnostics
Microbiology · 83d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · JSO
bioMerieux, Inc.
Microbiology · 98d
Cleared Jul 01, 2009
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
K081923 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 359d
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared Jun 02, 2009
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
K090206 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 125d
Cleared May 27, 2009
EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
K082858 · FQH
Alcavis International, Inc.
General Hospital · 240d
Cleared Apr 10, 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189 · FPA
Icu Medical, Inc.
General Hospital · 74d
Cleared Mar 24, 2009
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 109d
Cleared Mar 17, 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 55d
Cleared Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346 · LON
bioMerieux, Inc.
Microbiology · 213d
Cleared Feb 26, 2009
ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
K083103 · FRO
Acrymed, Inc.
General & Plastic Surgery · 129d
Not Cleared Feb 25, 2009
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
DEN070002 · NYS
Quick-Med Technologies, Inc.
General & Plastic Surgery · 657d
Cleared Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K083383 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Feb 18, 2009
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32...
K083262 · LTT
Siemens Healthcare Diagnostics
Microbiology · 105d
Cleared Jan 29, 2009
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
K082852 · LON
Becton, Dickinson & CO
Microbiology · 122d
Cleared Dec 30, 2008
MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
K083765 · FPA
Medegen Medical Manufacturing Services
General Hospital · 12d
Cleared Dec 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML
K082913 · LON
Becton, Dickinson & CO
Microbiology · 66d