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"
1009–1032 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Aug 16, 1996
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K962150 · LTT
Dade Intl., Inc.
Microbiology · 73d
Cleared Aug 13, 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · ELW
Dentsply Intl.
Dental · 435d
Cleared Aug 08, 1996
ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
K961194 · GBW
Sil-Med Corp.
General & Plastic Surgery · 134d
Cleared Jul 10, 1996
STREPTOMYCIN DISK (300MCG)
K961819 · JTN
Remel, L.P.
Microbiology · 61d
Cleared Jul 10, 1996
GENTAMICIN DISK (120MCG)
K961818 · JTN
Remel, L.P.
Microbiology · 61d
Cleared Jul 05, 1996
ETEST SUBMISSION FOR AZITHROMYCIN
K961519 · JWY
Ab Biodisk
Microbiology · 74d
Cleared Jul 05, 1996
ETEST SUBMISSION FOR CEFOTETAN
K961517 · JWY
Ab Biodisk
Microbiology · 74d
Cleared Jul 01, 1996
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · ETD
Xomed, Inc.
Ear, Nose, Throat · 47d
Cleared May 20, 1996
ETEST SUBMISSION FOR VANCOMYCIN
K960990 · JWY
Ab Biodisk
Microbiology · 70d
Cleared May 20, 1996
ETEST SUBMISSION FOR IMIPENEM
K960989 · JWY
Ab Biodisk
Microbiology · 70d
Cleared Apr 10, 1996
HAEMOPHILUS TEST MEDIUM (HTM)
K952595 · JSO
Clinical Standards Laboratories, Inc.
Microbiology · 309d
Cleared Apr 09, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960366 · LTT
Accumed Intl., Inc.
Microbiology · 75d
Cleared Apr 05, 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 10d
Cleared Apr 04, 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420 · JTZ
Becton Dickinson Microbiology Systems
Microbiology · 66d
Cleared Mar 27, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960235 · JWY
Accumed Intl., Inc.
Microbiology · 70d
Cleared Mar 25, 1996
MUELLER HINTON AGAR WITH 2% NACI
K960313 · JTZ
Remel, L.P.
Microbiology · 63d
Cleared Mar 11, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960220 · JWY
Sensititre , Ltd.
Microbiology · 55d
Cleared Feb 23, 1996
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K955910 · JWY
Dade Microscan, Inc.
Microbiology · 56d
Cleared Feb 23, 1996
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · JTN
Remel Co.
Microbiology · 72d
Cleared Feb 22, 1996
THE E TEST CEFTIZOXIME
K955920 · JWY
Ab Biodisk
Microbiology · 113d
Cleared Dec 12, 1995
AMOXICILLIN/CLAVULANIC ACID 2/1
K954319 · JWY
Ab Biodisk
Microbiology · 90d
Cleared Oct 16, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · JSO
Hardy Diagnostics
Microbiology · 182d
Cleared Oct 07, 1995
FOX FASTIDIOUS TEST PANELS
K953422 · JWY
Micro-Media Systems, Inc.
Microbiology · 92d
Cleared Oct 07, 1995
HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
K951241 · JWY
Radiometer America, Inc.
Microbiology · 222d