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"
265–288 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Jun 10, 2016
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science...
K160095 · FRO
Simple Science, LLC
General & Plastic Surgery · 143d
Cleared Jun 02, 2016
MTR550 (Tentative) Antimicrobial Silver Wound Gel
K152519 · FRO
Medical Technology Research, Inc.
General & Plastic Surgery · 273d
Cleared Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
K152075 · LON
bioMerieux, Inc.
Microbiology · 263d
Cleared Apr 08, 2016
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic...
K160223 · NHC
Cook Incorporated
Neurology · 70d
Cleared Mar 31, 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
K153687 · JWY
Liofilchem S. R. L.
Microbiology · 99d
Cleared Mar 11, 2016
chromID MRSA
K151688 · JSO
bioMerieux, Inc.
Microbiology · 262d
Cleared Jan 15, 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
K151320 · LON
Becton, Dickinson and Company
Microbiology · 242d
Cleared Jan 13, 2016
Sonishield 100 Antimicrobial Ultrasound Gel
K151070 · MUI
Quotient Medical
Radiology · 267d
Cleared Dec 29, 2015
SpectraShield 9500 Surgical N95 Respirator
K150729 · ONT
Nexera Medical, Inc.
General Hospital · 284d
Cleared Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K152774 · JWY
Thermo Fisher Scientific
Microbiology · 87d
Cleared Nov 24, 2015
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
K152846 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Nov 24, 2015
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
K152838 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Nov 19, 2015
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R)...
K150799 · FRO
Innovacyn, Inc.
General & Plastic Surgery · 238d
Cleared Nov 05, 2015
BD ChloraShield IV Dressing with CHG Antimicrobial
K152923 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 31d
Cleared Oct 13, 2015
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial...
K152516 · JTN
Becton, Dickinson and Company
Microbiology · 40d
Cleared Oct 07, 2015
Etest Ceftaroline (0.002 - 32ug/ml)
K151873 · JWY
Biomerieux S.A.
Microbiology · 90d
Cleared Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · JWY
Beckman Coulter, Inc.
Microbiology · 27d
Cleared Aug 28, 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with...
K150556 · JWY
Thermo Fisher Scientific
Microbiology · 177d
Cleared Jul 27, 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K150236 · JWY
Thermo Fisher Scientific
Microbiology · 175d
Cleared Jul 02, 2015
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
K150039 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 174d
Cleared Apr 01, 2015
Sensititre Susceptibility plates
K143288 · JWY
Thermo Fisher Scientific
Microbiology · 135d
Cleared Mar 05, 2015
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
K143526 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 02, 2015
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
K142338 · JWY
Thermo Fisher Scientific
Microbiology · 193d
Cleared Feb 19, 2015
Sensititre Susceptibility Plates
K143381 · JWY
Thermo Fisher Scientific
Microbiology · 86d