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"
961–984 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Aug 20, 1997
PASCO MIC AND MIC/ID PANELS
K972567 · JWY
Pasco Laboratories, Inc.
Microbiology · 50d
Cleared Aug 20, 1997
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971638 · JTN
Oxoid , Ltd.
Microbiology · 110d
Cleared Aug 15, 1997
PASCO MIC AND MIC/ID PANELS
K971951 · JWY
Pasco Laboratories, Inc.
Microbiology · 79d
Cleared Aug 13, 1997
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971632 · JTN
Oxoid , Ltd.
Microbiology · 103d
Cleared Aug 01, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K972180 · JWY
Dade Microscan, Inc.
Microbiology · 52d
Cleared Jul 28, 1997
FOSFOMYCIN, 200 MG, SENSI-DISC
K972098 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 54d
Cleared Jul 18, 1997
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392 · FJS
Sil-Med Corp.
Gastroenterology & Urology · 463d
Cleared Jul 14, 1997
ETEST FOR LEVOFLOXACIN
K971697 · JWY
Ab Biodisk
Microbiology · 67d
Cleared Jul 03, 1997
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971635 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jul 03, 1997
PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971633 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jul 03, 1997
CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971631 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jun 30, 1997
ETEST FOR CEFTAZIDIME
K971694 · JWY
Ab Biodisk
Microbiology · 54d
Cleared May 30, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K971376 · JWY
Dade Microscan, Inc.
Microbiology · 46d
Cleared May 02, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K970676 · JWY
Dade Intl., Inc.
Microbiology · 67d
Cleared May 01, 1997
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
K970473 · JWY
Ab Biodisk
Microbiology · 83d
Cleared May 01, 1997
AMIKACIN
K970210 · JWY
Ab Biodisk
Microbiology · 100d
Cleared May 01, 1997
(MODIFIED) ETEST PACKAGE INSERT
K964236 · JWY
Ab Biodisk
Microbiology · 195d
Cleared Apr 25, 1997
ETEST SPARFLOXACIN
K970820 · JWY
Ab Biodisk
Microbiology · 50d
Cleared Apr 14, 1997
DISPENS-O-DISC SPARFLOXACIN
K971211 · JTN
Difco Laboratories, Inc.
Microbiology · 18d
Cleared Apr 14, 1997
DISPENS-O-DISC (TM) LEVOFLOXACIN
K971120 · JTN
Difco Laboratories, Inc.
Microbiology · 18d
Cleared Apr 02, 1997
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
K970831 · JTN
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
K970830 · JTN
Remel, Inc.
Microbiology · 26d
Cleared Mar 19, 1997
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
K965190 · JWY
Accumed Intl., Inc.
Microbiology · 85d
Cleared Mar 10, 1997
SPARFLOZACIN, 5 MCG, SENSI-DISC
K970385 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 35d