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"
337–360 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Dec 14, 2011
EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
K111313 · FQH
Alcavis Hdc, LLC
General Hospital · 218d
Cleared Nov 30, 2011
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
K110106 · LON
bioMerieux, Inc.
Microbiology · 321d
Cleared Nov 16, 2011
VIZION
K112276 · JWY
Trek Diagnostic Systems
Microbiology · 99d
Cleared Nov 08, 2011
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
K111615 · JWY
Trek Diagnostic Systems
Microbiology · 151d
Cleared Oct 26, 2011
VITEK 2 STREPTOCOCCUS PENICILLIN
K112000 · LON
bioMerieux, Inc.
Microbiology · 105d
Cleared Oct 21, 2011
VRESELECT CULTURE MEDIUM
K103684 · JSO
Bio-Rad
Microbiology · 308d
Cleared Oct 18, 2011
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
K112586 · JTN
Becton, Dickinson and Company (BD)
Microbiology · 42d
Cleared Oct 18, 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
K111909 · LON
bioMerieux, Inc.
Microbiology · 105d
Cleared Oct 14, 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
K103752 · LON
bioMerieux, Inc.
Microbiology · 295d
Cleared Oct 03, 2011
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
K112228 · LON
bioMerieux, Inc.
Microbiology · 61d
Cleared Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
K112129 · LON
bioMerieux, Inc.
Microbiology · 63d
Cleared Sep 15, 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
K112075 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Aug 18, 2011
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND...
K111429 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 87d
Cleared Aug 12, 2011
VITEK 2 AST-ST LINEZOLID
K111599 · LON
bioMerieux, Inc.
Microbiology · 65d
Cleared Jun 22, 2011
MICROSCAN MICROSTEP
K111394 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 35d
Cleared May 26, 2011
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM...
K101128 · OUK
Filligent Limited
General Hospital · 399d
Cleared May 16, 2011
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
K102535 · JWY
Biomerieux S.A.
Microbiology · 255d
Cleared May 04, 2011
HARDYCHROM MRSA
K102922 · JSO
Hardy Diagnostics
Microbiology · 215d
Cleared Mar 30, 2011
CHLORASHIELD TM ANTIMICROBIAL DRESSING
K103106 · FRO
Care Fusion 213, LLC
General & Plastic Surgery · 161d
Cleared Mar 14, 2011
SILVER ANTIMICROBIAL WOUND GEL
K110458 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 25d
Cleared Feb 24, 2011
SPECTRASHIELD 9500 SURGICAL MASK
K090414 · ONT
Nexera Medical, Inc.
General Hospital · 736d
Cleared Dec 17, 2010
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
K103538 · JTN
Hardy Diagnostics
Microbiology · 15d
Cleared Dec 10, 2010
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
K100261 · FRO
Tei Biosciences, Inc.
General & Plastic Surgery · 316d
Cleared Nov 17, 2010
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
K102668 · JWY
BIOMERIEUX
Microbiology · 62d