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"
985–1008 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Mar 06, 1997
LEVOFLOXACIN, 5MCG, SENSI-DISC
K970212 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 44d
Cleared Feb 07, 1997
CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964495 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964492 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964491 · JTN
Unipath , Ltd.
Microbiology · 92d
Cleared Feb 07, 1997
AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964490 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964489 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964487 · JTN
Unipath , Ltd.
Microbiology · 92d
Cleared Feb 06, 1997
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964512 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964501 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC
K964496 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964493 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 04, 1997
CETIBUTEN, 30MCG, SENSI-DISC
K965159 · JTN
Becton Dickinson Microbiology Systems
Immunology · 43d
Cleared Jan 15, 1997
BHI W/VANCOMYCIN AGAR
K964560 · JSO
Hardy Diagnostics
Microbiology · 63d
Cleared Dec 18, 1996
PIPERACILLIN/TAZOBACTAM 4
K964203 · JWY
Ab Biodisk
Microbiology · 77d
Cleared Dec 18, 1996
STREPTOCOCCUS MIC PANEL
K963641 · JWY
Dade Microscan, Inc.
Microbiology · 97d
Cleared Dec 06, 1996
REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
K964421 · JTN
Remel, L.P.
Microbiology · 66d
Cleared Oct 25, 1996
MEROPENEM, 10 MCG, SENSI-DISC
K963845 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 30d
Cleared Oct 24, 1996
ETEST FOR CEFEPIME
K963107 · JWY
Ab Biodisk
Microbiology · 73d
Cleared Oct 15, 1996
HAEMOPHILUS TEST MEDIUM AGAR (HTM)
K962744 · JSO
Prepared Media Laboratory, Inc.
Microbiology · 92d
Cleared Oct 08, 1996
ETEST SUBMISSION FOR AMOXICILLIN
K960991 · JWY
Ab Biodisk
Microbiology · 211d
Cleared Oct 07, 1996
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K963036 · JTZ
Becton Dickinson Microbiology Systems
Microbiology · 63d
Cleared Sep 30, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K962867 · JWY
Sensititre Alamar
Microbiology · 69d
Cleared Sep 26, 1996
DISPENS-O-DISC MEROPENEM
K963508 · JTN
Difco Laboratories, Inc.
Microbiology · 23d
Cleared Aug 30, 1996
ETEST FOR AZTREONAM
K962794 · JWY
Ab Biodisk
Microbiology · 44d