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"
553–576 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Jun 15, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML
K051109 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 302d
Cleared Jun 06, 2005
COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
K043296 · FRO
Covalontechnologies, Inc.
General & Plastic Surgery · 189d
Cleared Jun 03, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML
K051138 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared May 27, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML
K050946 · LON
Becton, Dickinson & CO
Microbiology · 42d
Cleared May 24, 2005
BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)
K050982 · LON
Becton, Dickinson & CO
Microbiology · 35d
Cleared May 23, 2005
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K050976 · LON
bioMerieux, Inc.
Microbiology · 35d
Cleared May 20, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE...
K050865 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared May 12, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16...
K050881 · LON
Becton, Dickinson & CO
Microbiology · 35d
Cleared May 12, 2005
VITEK 2 GRAM POSITIVE MEROPENEM
K050816 · LON
bioMerieux, Inc.
Microbiology · 42d
Cleared May 12, 2005
BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML
K050780 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Apr 29, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML
K050747 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Apr 29, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML
K050745 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Apr 14, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML
K050555 · LON
Becton, Dickinson & CO
Microbiology · 42d
Cleared Mar 22, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML
K050400 · LON
Becton, Dickinson & CO
Microbiology · 34d
Cleared Mar 15, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML
K043458 · LON
Becton, Dickinson & CO
Microbiology · 90d
Cleared Feb 28, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML
K050089 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Feb 28, 2005
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K050075 · LON
bioMerieux, Inc.
Microbiology · 47d
Cleared Feb 18, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM
K050076 · LON
bioMerieux, Inc.
Microbiology · 37d
Cleared Feb 17, 2005
VITEK 2 COMPACT
K050002 · LON
bioMerieux, Inc.
Microbiology · 45d
Cleared Feb 14, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
K043589 · JWY
Dade Microscan, Inc.
Microbiology · 48d
Cleared Feb 10, 2005
GEMIFLOXACIN, 5UG BBL SENSI-DISC
K050062 · JTN
Becton, Dickinson & CO
Microbiology · 30d
Cleared Jan 21, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN)...
K043389 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Dec 30, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
K043230 · LON
bioMerieux, Inc.
Microbiology · 38d