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"
625–648 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Oct 29, 2003
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
K032962 · FOZ
Arrow Intl., Inc.
General Hospital · 36d
Cleared Oct 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML
K032655 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Sep 29, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE...
K032275 · LON
Becton, Dickinson & CO
Microbiology · 68d
Cleared Sep 22, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML
K032299 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Sep 17, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
K032567 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Sep 15, 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
K032518 · JWY
Bd Diagnostic Systems
Microbiology · 32d
Cleared Sep 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
K032153 · LON
Bd Diagnostic Systems
Microbiology · 59d
Cleared Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399 · LON
bioMerieux, Inc.
Microbiology · 37d
Cleared Aug 29, 2003
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K032382 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 28d
Cleared Aug 27, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
K031984 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Aug 22, 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
K032314 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 19, 2003
PASCO MIC AND MIC/ID PANELS
K032259 · JWY
Bd Diagnostic Systems
Microbiology · 28d
Cleared Aug 18, 2003
BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE...
K032131 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
K031865 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Aug 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML
K031943 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jul 31, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN...
K031602 · LON
Dade Behring, Inc.
Microbiology · 71d
Cleared Jul 30, 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN
K031727 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 30, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...
K031699 · LON
Becton, Dickinson & CO
Microbiology · 58d
Cleared Jul 21, 2003
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE...
K031912 · LON
Becton, Dickinson & CO
Microbiology · 31d
Cleared Jul 16, 2003
BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM
K031679 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jul 16, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
K031545 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 61d
Cleared Jul 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE
K031589 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Jul 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
K031530 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Jul 10, 2003
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
K031410 · LON
bioMerieux, Inc.
Microbiology · 66d