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"
289–312 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Dec 23, 2014
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K142151 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Nov 07, 2014
CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4...
K140389 · FRO
Entrotech Life Sciences, Inc.
General & Plastic Surgery · 266d
Cleared Oct 28, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
K142170 · LON
Becton, Dickinson and Company
Microbiology · 82d
Cleared Oct 21, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141651 · JWY
Thermo Fisher Scientific
Microbiology · 123d
Cleared Sep 12, 2014
SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON...
K141033 · OMP
Argentum Medical, LLC
General & Plastic Surgery · 143d
Cleared Aug 01, 2014
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
K133847 · JWY
Thermo Fisher Scientific
Microbiology · 226d
Cleared Jul 25, 2014
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
K140250 · KKX
3M Healthcare
General Hospital · 175d
Cleared Jul 16, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141000 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Jun 30, 2014
MUELLER HINTON AGAR
K132491 · JTZ
Edge Biologicals, Inc.
Microbiology · 326d
Cleared Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
K141149 · LON
bioMerieux, Inc.
Microbiology · 46d
Cleared Jun 10, 2014
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
K140985 · JWY
Thermo Fisher Scientific
Microbiology · 55d
Cleared Jun 02, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
K140468 · LON
Becton, Dickinson and Company
Microbiology · 97d
Cleared Apr 22, 2014
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
K140147 · FRO
Bio-Medical Carbon Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Mar 13, 2014
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
K133764 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 92d
Cleared Feb 28, 2014
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K132580 · GAM
Ethicon, Inc.
General & Plastic Surgery · 196d
Cleared Feb 27, 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Feb 14, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
K132909 · LON
Becton, Dickinson and Company
Microbiology · 150d
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674 · LON
Becton, Dickinson and Company
Microbiology · 122d
Cleared Nov 15, 2013
VITEK 2 AST ST MEROPENEM
K132507 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared Nov 08, 2013
MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
K131275 · LTT
Siemens Helathcare Diagnostics, Inc.
Microbiology · 189d
Cleared Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
K131779 · LON
bioMerieux, Inc.
Microbiology · 115d
Cleared Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
K132573 · LON
bioMerieux, Inc.
Microbiology · 28d
Cleared Jul 10, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
K131331 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Jun 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
K123404 · LON
Becton, Dickinson & CO
Microbiology · 234d