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"
457–480 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Jul 12, 2007
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
K071640 · NHC
Cook, Inc.
Neurology · 27d
Cleared Jul 10, 2007
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
K070333 · FRO
Acrymed, Inc.
General & Plastic Surgery · 155d
Cleared Jun 26, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
K071268 · LON
Dade Behring, Inc.
Microbiology · 50d
Cleared May 21, 2007
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K071076 · LON
Dade Behring, Inc.
Microbiology · 35d
Cleared May 11, 2007
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN
K070860 · LON
Dade Behring, Inc.
Microbiology · 44d
Cleared Apr 16, 2007
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED...
K063271 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 168d
Cleared Mar 14, 2007
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K070262 · JTN
Oxoid , Ltd.
Microbiology · 47d
Cleared Mar 07, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM...
K063486 · LON
Becton, Dickinson & CO
Microbiology · 110d
Cleared Feb 14, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML
K063824 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Feb 09, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML
K063811 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Feb 08, 2007
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL...
K063564 · LON
Dade Behring, Inc.
Microbiology · 72d
Cleared Jan 29, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML
K063300 · LON
Becton, Dickinson & CO
Microbiology · 89d
Cleared Jan 29, 2007
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
K062559 · FRO
Laboratoires Urgo
General & Plastic Surgery · 152d
Cleared Jan 19, 2007
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K063597 · LON
bioMerieux, Inc.
Microbiology · 46d
Cleared Jan 11, 2007
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
K063623 · LON
bioMerieux, Inc.
Microbiology · 36d
Cleared Jan 11, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML
K063573 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Dec 21, 2006
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K063492 · LON
bioMerieux, Inc.
Microbiology · 34d
Cleared Dec 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY...
K062841 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 89d
Cleared Dec 08, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID...
K063366 · LON
Dade Behring, Inc.
Microbiology · 31d
Cleared Dec 08, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML...
K063365 · LON
Dade Behring, Inc.
Microbiology · 31d
Cleared Dec 08, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML
K063301 · LON
Becton, Dickinson & CO
Microbiology · 37d
Cleared Nov 21, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML
K062945 · LON
Becton, Dickinson & CO
Microbiology · 54d
Cleared Nov 21, 2006
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S
K062212 · FRO
Anacapa Technologies, Inc.
General & Plastic Surgery · 112d
Cleared Nov 20, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN...
K062938 · LON
Dade Behring, Inc.
Microbiology · 53d