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"
793–816 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Oct 19, 2000
HARDYDISK NETILMICIN, 30MCG
K002663 · JTN
Hardy Diagnostics
Microbiology · 55d
Cleared Oct 13, 2000
ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
K002909 · FRO
Acrymed, Inc.
General & Plastic Surgery · 25d
Cleared Sep 21, 2000
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041,...
K002599 · FRO
Acrymed, Inc.
General & Plastic Surgery · 31d
Cleared Sep 05, 2000
LINEZOLID, 30UG, BBL SENSI-DISC
K002165 · JTN
Dickinson, and Co.
Microbiology · 49d
Cleared Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
K000251 · MJC
Cook Urological, Inc.
Gastroenterology & Urology · 216d
Cleared Aug 10, 2000
PASCO MIC AND MIC/ID PANELS
K001953 · JWY
Pasco Laboratories, Inc.
Microbiology · 44d
Cleared Aug 09, 2000
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
K001887 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Aug 07, 2000
ETEST ESBL CT/CTL STRIP
K001547 · JWY
Ab Biodisk
Microbiology · 81d
Cleared Aug 04, 2000
PASCO MIC AND MIC/ID PANELS
K001721 · LTT
Pasco Laboratories, Inc.
Microbiology · 59d
Cleared Jul 27, 2000
HARDY DISK CLARITHROMYCIN, 15MCG
K001728 · JTN
Hardy Diagnostics
Microbiology · 50d
Cleared Jul 24, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
K001558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Jul 18, 2000
PASCO MIC AND MIC/ID PANELS
K001612 · JWY
Pasco Laboratories, Inc.
Microbiology · 54d
Cleared Jul 18, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K001573 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Jul 12, 2000
PASCO MIC AND MIC/ID PANELS
K001516 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 07, 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
K001143 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 88d
Cleared Jun 07, 2000
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
K992221 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 342d
Cleared Jun 07, 2000
HARDYDISK CINOXACIN, 100 MCG
K001487 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Jun 06, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
K001036 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Jun 01, 2000
HARDYDISK CEFONICID, 30 MCG
K001490 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared Jun 01, 2000
HARDYDISK CEFOPERAZONE, 75 MCG
K001489 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared May 23, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
K001035 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 53d
Cleared May 22, 2000
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000930 · JTN
Oxoid , Ltd.
Microbiology · 61d
Cleared May 22, 2000
ETEST GATIFLOXACIN
K000596 · JWY
Ab Biodisk
Microbiology · 90d
Cleared May 18, 2000
ETEST MOXIFLOXACIN
K000298 · JWY
Ab Biodisk
Microbiology · 108d