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"
361–384 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Nov 03, 2010
PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 120d
Cleared Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589 · JSO
Bio-Rad
Microbiology · 241d
Cleared Oct 21, 2010
VITEK 2 GRAM POSITIVE DOXCYCLINE
K093076 · LON
bioMerieux, Inc.
Microbiology · 386d
Cleared Oct 08, 2010
REMEL SPECTRA MRSA
K092407 · JSO
Remel, Inc.
Microbiology · 428d
Cleared Aug 27, 2010
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER...
K100635 · LJS
Arrow Intl., Inc.
General Hospital · 175d
Cleared Aug 25, 2010
ETEST MOXIFLOXACIN 0.002-32 UG/ML
K093604 · JWY
Ab Biomerieux
Microbiology · 278d
Cleared Aug 20, 2010
BBL CHROMAGAR MRSA II
K092767 · JSO
Becton, Dickinson & CO
Microbiology · 345d
Cleared Aug 10, 2010
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
K100693 · FRO
Medtrade Products Limited
General & Plastic Surgery · 152d
Cleared Jul 15, 2010
REMEL SPECTRA VRE
K092819 · JSO
Thermo Fisher Scientific
Microbiology · 304d
Cleared Jul 02, 2010
ACTIPROTECT UC N95 RESPIRATOR
K093189 · ORW
Glaxosmithkline Consumer Healthcare
General Hospital · 266d
Cleared Jun 11, 2010
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
K100430 · FRO
Laboratoires Urgo
General & Plastic Surgery · 115d
Cleared Jun 11, 2010
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
K100429 · FRO
Laboratoires Urgo
General & Plastic Surgery · 115d
Cleared Jun 08, 2010
GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA...
K093729 · QSY
Hemcon Medical Technologies Europe, Ltd.
General & Plastic Surgery · 187d
Cleared May 10, 2010
ACTIPROTECT UF N95 RESPIRATOR
K093161 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 216d
Cleared Apr 08, 2010
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS
K092351 · FRO
Polyremedy, Inc.
General & Plastic Surgery · 247d
Cleared Apr 08, 2010
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
K092348 · FRO
Polyremedy, Inc.
General & Plastic Surgery · 247d
Cleared Mar 29, 2010
TELAVANCIN 30 UG, BBL SENSI-DISC
K100722 · JTN
Becton, Dickinson and Company
Microbiology · 14d
Cleared Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
K091025 · JSO
bioMerieux, Inc.
Microbiology · 326d
Cleared Feb 25, 2010
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC...
K093741 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 83d
Cleared Feb 17, 2010
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
K093865 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jan 26, 2010
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
K091949 · LTT
Siemens Healthcare Diagnostics
Microbiology · 209d
Cleared Jan 08, 2010
HARDYDISK AST TELAVANCIN,30UG
K093807 · JTN
Hardy Diagnostics
Microbiology · 28d
Cleared Jan 07, 2010
MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL
K090345 · FRO
Conseal International, Inc.
General & Plastic Surgery · 331d
Cleared Dec 16, 2009
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K092445 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 128d