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"
433–456 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Feb 28, 2008
SPECTRA MRSA
K073027 · JSO
Thermo Fisher Scientific
Microbiology · 125d
Cleared Jan 29, 2008
HARDYDISK AST DORIPENEM 10 UG
K080019 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K073406 · LON
bioMerieux, Inc.
Microbiology · 50d
Cleared Jan 22, 2008
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K073424 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 48d
Cleared Jan 16, 2008
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
K063091 · FTL
Tyrx Pharma, Inc.
General & Plastic Surgery · 463d
Cleared Jan 14, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
K073433 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Dec 20, 2007
ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
K071885 · OED
Philips Medical Systems
Cardiovascular · 164d
Cleared Dec 10, 2007
VITEK 2 GRAM NEGATIVE PIPERACILLIN
K073083 · LON
bioMerieux, Inc.
Microbiology · 39d
Cleared Nov 19, 2007
COPA AMD ANTIMICROBIAL WOUND DRESSING
K071371 · FRO
Tyco Healthcare Group LP
General & Plastic Surgery · 187d
Cleared Nov 16, 2007
VITEK 2 GRAM POSITIVE TIGECYCLINE
K072695 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Nov 09, 2007
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS...
K072378 · FRO
Arthrex, Inc.
General & Plastic Surgery · 77d
Cleared Nov 06, 2007
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH...
K072576 · FPA
Baxter Healthcare Corp
General Hospital · 54d
Cleared Oct 15, 2007
VITEK 2 GRAM POSITIVE VANCOMYCIN
K072668 · LON
bioMerieux, Inc.
Microbiology · 24d
Cleared Sep 24, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
K070809 · LON
Becton, Dickinson & CO
Microbiology · 182d
Cleared Sep 14, 2007
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
K070685 · FRO
Tyco Healthcare
General & Plastic Surgery · 186d
Cleared Sep 13, 2007
MRSASELECT
K070361 · JSO
Bio-Rad
Microbiology · 218d
Cleared Sep 12, 2007
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
K072038 · LON
bioMerieux, Inc.
Microbiology · 49d
Cleared Sep 12, 2007
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
K070653 · FRO
Tyco Healthcare
General & Plastic Surgery · 187d
Cleared Aug 22, 2007
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG...
K071703 · FRO
Swiss American Products, Inc.
General & Plastic Surgery · 62d
Cleared Aug 20, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN)...
K071623 · LON
Becton, Dickinson & CO
Microbiology · 67d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW...
K071317 · LON
Dade Behring, Inc.
Microbiology · 102d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW...
K071316 · LRG
Dade Behring, Inc.
Microbiology · 102d
Cleared Jul 18, 2007
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
K070346 · LON
Dade Behring, Inc.
Microbiology · 162d
Cleared Jul 13, 2007
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
K063805 · FRO
Nucryst Pharmaceuticals, Inc.
General & Plastic Surgery · 203d