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"
1033–1056 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Oct 07, 1995
JUSTONE
K951240 · JWY
Radiometer America, Inc.
Microbiology · 222d
Cleared Aug 15, 1995
PIPERACILIN TAZOBACTAM 4 UG
K953223 · JWY
Ab Biodisk
Microbiology · 123d
Cleared Jul 18, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K934458 · JWY
Baxter Diagnostics, Inc.
Microbiology · 673d
Cleared Jul 13, 1995
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
K936305 · JWY
Radiometer America, Inc.
Microbiology · 569d
Cleared Jul 07, 1995
TICARCILLIN/CLAVULANIC ACID 2
K951879 · JWY
Ab Biodisk
Microbiology · 84d
Cleared Jun 13, 1995
ENTEROCOCCUS SCREENING MEDIUM
K951539 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 71d
Cleared May 02, 1995
E TEST FOR OFLOXACIN
K946364 · JWY
Ab Biodisk
Microbiology · 134d
Cleared Apr 25, 1995
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · JWY
Baxter Diagnostics, Inc.
Microbiology · 62d
Cleared Apr 14, 1995
AMOXICILLIN/CLAVULANIC ACID 2/1
K950328 · JWY
Ab Biodisk North America, Inc.
Microbiology · 85d
Cleared Apr 14, 1995
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704 · LTT
Baxter Diagnostics, Inc.
Microbiology · 500d
Cleared Apr 04, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
K945911 · JTZ
Bioclinical Systems, Inc.
Microbiology · 123d
Cleared Mar 23, 1995
SCEPTOR SYSTEM PANELS
K950123 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 70d
Cleared Mar 17, 1995
ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
K945433 · JWY
Ab Biodisk
Microbiology · 144d
Cleared Mar 07, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K945235 · LTT
Baxter Diagnostics, Inc.
Microbiology · 131d
Cleared Feb 24, 1995
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
K944753 · JWY
Radiometer America, Inc.
Microbiology · 151d
Cleared Feb 17, 1995
MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION...
K943756 · JWY
Alamar Biosciences, Inc.
Microbiology · 199d
Cleared Feb 16, 1995
MODIFIED FOX EXTRA GRAM POSITIVE
K945997 · JWY
Micro-Media Systems, Inc.
Microbiology · 132d
Cleared Feb 16, 1995
DRIED GRAM-NEGATIVE CEFPODOXIME
K941030 · LTT
Baxter Diagnostics, Inc.
Microbiology · 349d
Cleared Feb 16, 1995
FAS FASTIDIOUS MIC PANEL
K935485 · JWY
Microtech Medical Systems, Inc.
Microbiology · 458d
Cleared Feb 08, 1995
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · JWY
Baxter Diagnostics, Inc.
Microbiology · 348d
Cleared Feb 03, 1995
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · JWY
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Feb 02, 1995
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
K945569 · JSO
Becton Dickinson Microbiology Systems
Microbiology · 114d
Cleared Jan 31, 1995
DRIED GRAM NEGATIVE/CEFMETAZOLE
K941317 · JWY
Baxter Diagnostics, Inc.
Microbiology · 319d
Cleared Jan 27, 1995
BBL CRYSTAL MRSA ID SYSTEM
K941997 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 277d