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"
529–552 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Nov 30, 2005
ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
K051401 · BSO
I-Flow Corp.
Anesthesiology · 183d
Cleared Nov 17, 2005
TIGECYCLINE 15UG BBL SENSI-DISC
K052853 · JTN
Becton, Dickinson & CO
Microbiology · 37d
Cleared Nov 14, 2005
TELITHROMYCIN 15UG BBL SENSI-DISC
K052876 · JTN
Becton, Dickinson & CO
Microbiology · 33d
Cleared Nov 08, 2005
FORTADERM ANTIMICROBIAL WOUND DRESSING
K051647 · FRO
Organogenesis, Inc.
General & Plastic Surgery · 140d
Cleared Nov 07, 2005
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
K052656 · LON
bioMerieux, Inc.
Microbiology · 42d
Cleared Oct 26, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K052346 · LON
Dade Behring, Inc.
Microbiology · 58d
Cleared Oct 13, 2005
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA,...
K052366 · JWY
Ab Biodisk
Microbiology · 45d
Cleared Oct 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML
K052270 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Oct 03, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN
K052269 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Sep 30, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
K052250 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Sep 29, 2005
VITEK 2 GRAM NEGATIVE TIGECYCLINE
K052311 · LON
bioMerieux, Inc.
Microbiology · 36d
Cleared Sep 21, 2005
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Sep 09, 2005
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · LRX
Ciba Vision Corporation
Ophthalmic · 430d
Cleared Aug 16, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
K051849 · LON
bioMerieux, Inc.
Microbiology · 40d
Cleared Aug 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML
K051689 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jul 27, 2005
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN
K051478 · LON
Dade Behring, Inc.
Microbiology · 54d
Cleared Jul 25, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K051350 · LON
Dade Behring, Inc.
Microbiology · 62d
Cleared Jul 14, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML
K051692 · LON
Becton, Dickinson & CO
Microbiology · 21d
Cleared Jul 12, 2005
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO...
K051311 · LON
Dade Behring, Inc.
Microbiology · 54d
Cleared Jul 11, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML
K051272 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Jul 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML
K051266 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Jun 24, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML
K051204 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jun 23, 2005
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K051202 · JWY
Dade Behring, Inc.
Microbiology · 43d
Cleared Jun 21, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML
K051183 · LON
Becton, Dickinson & CO
Microbiology · 43d