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"
313–336 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Jun 26, 2013
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
K123266 · LON
Becton, Dickinson and Company
Microbiology · 250d
Cleared Jun 04, 2013
ULTRACHECK CURVE BLOOD PRESSURE CUFFS
K122365 · OED
Statcorp Medical
Cardiovascular · 302d
Cleared Mar 18, 2013
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
K122702 · ONT
Filligent Limited
General Hospital · 195d
Cleared Mar 14, 2013
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
K123933 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
Cleared Nov 20, 2012
VITEK 2 GRAM NEGATIVE DOXYCYCLINE
K121546 · LON
bioMerieux, Inc.
Microbiology · 179d
Cleared Nov 19, 2012
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
K121100 · LON
bioMerieux, Inc.
Microbiology · 222d
Cleared Nov 06, 2012
VRESELECT CULTURE MEDIUM
K122187 · JSO
Bio-Rad
Microbiology · 105d
Cleared Oct 15, 2012
GRAM POSTITVE CLINDAMYCIN
K122547 · LON
bioMerieux, Inc.
Microbiology · 55d
Cleared Oct 12, 2012
ETEST CEFTAROLINE
K121002 · JWY
bioMerieux, Inc.
Microbiology · 193d
Cleared Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
K122359 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 21, 2012
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
K121485 · QSY
Hemcon Medical Technologies Europe, Ltd.
General & Plastic Surgery · 95d
Cleared Aug 16, 2012
VITEK 2 AST-ST CEFOTAXIME
K121863 · LON
bioMerieux, Inc.
Microbiology · 51d
Cleared Aug 13, 2012
SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE...
K121819 · FRO
Covalontechnologies, Inc.
General & Plastic Surgery · 53d
Cleared Aug 08, 2012
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER
K113820 · FRO
Novabay Pharmaceuticals
General & Plastic Surgery · 225d
Cleared Aug 07, 2012
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K113783 · LON
bioMerieux, Inc.
Microbiology · 229d
Cleared Jul 20, 2012
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
K113229 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 261d
Cleared Jul 05, 2012
SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
K120244 · ONT
Nexera Medical, Inc.
General Hospital · 160d
Cleared Jun 29, 2012
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
K113200 · LON
bioMerieux, Inc.
Microbiology · 242d
Cleared Jun 27, 2012
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
K121522 · FRO
Polyremedy, Inc.
General & Plastic Surgery · 35d
Cleared May 04, 2012
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE...
K112549 · FRO
Covalontechnologies, Inc.
General & Plastic Surgery · 246d
Cleared Feb 28, 2012
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
K111893 · LON
bioMerieux, Inc.
Microbiology · 238d
Cleared Feb 17, 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · LON
bioMerieux, Inc.
Microbiology · 220d
Cleared Feb 10, 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · LON
bioMerieux, Inc.
Microbiology · 93d
Not Cleared Dec 20, 2011
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50
DEN100013 · OSZ
Vioguard
General Hospital · 410d