Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
2137–2160 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 02, 2000
HARDYDISK TICARILLIN 75MCG
K000175 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Mar 02, 2000
HARDYDISK, CARBENICILLIN, 100MCG
K000181 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Mar 02, 2000
BACT/ALERT MB CULTURE BOTTLE
K000378 · MDB
Organon Teknika Corp.
Microbiology · 24d
Cleared Feb 29, 2000
HARDYDISK, NALIDIXIC ACID, 30MCG
K000130 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Feb 29, 2000
HARDYDISK TOBRAMYCIN, 10MCG
K000182 · JTN
Hardy Diagnostics
Microbiology · 40d
Cleared Feb 29, 2000
HARDYDISK, STREPTOMYCIN 10MCG
K000201 · JTN
Hardy Diagnostics
Microbiology · 39d
Cleared Feb 29, 2000
HYBRID CAPTURE II CT/GC TEST
K981567 · LSL
Digene Corp.
Microbiology · 669d
Cleared Feb 28, 2000
HARDYDISK, PIPERACILLIN, 100MCG
K000183 · JTN
Hardy Diagnostics
Microbiology · 39d
Cleared Feb 28, 2000
DRYSPOT E.COLI 0157 KIT
K993401 · GNA
Oxoid , Ltd.
Microbiology · 143d
Cleared Feb 24, 2000
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
K000316 · MSQ
Meretek
Microbiology · 23d
Cleared Feb 23, 2000
SYNTHETIC VDRL ANTIGEN
K993633 · GMQ
Centers For Disease Control and...
Microbiology · 119d
Cleared Feb 18, 2000
HARDYDISK, CEFAZOLIN, 30MCG
K000128 · JTN
Hardy Diagnostics
Microbiology · 31d
Cleared Feb 18, 2000
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943 · JWY
Dade Microscan, Inc.
Microbiology · 470d
Cleared Feb 17, 2000
HARDYDISK CEFAMANDOLE, 30MCG
K000022 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Feb 17, 2000
HARDYDISK OXACILLIN, 1MCG
K994134 · JTN
Hardy Diagnostics
Microbiology · 72d
Cleared Feb 16, 2000
HARDYDISK ERYTHROMYCIN, 15MCG
K994135 · JTN
Hardy Diagnostics
Microbiology · 71d
Cleared Feb 16, 2000
HARDYDISK NORFLOXACIN, 10MCG
K994150 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 15, 2000
HARDYDISK MEZLOCILLIN 75MCG
K994212 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Feb 11, 2000
HARDYDISK CHLORAMPHENICOL, 30MCG
K994089 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 11, 2000
HARDYDISK GENTAMICIN, 10MCG
K994091 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 11, 2000
HARDYDISK CEFIXIME, 5MCG
K994129 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared Feb 10, 2000
COPALIS RUBELLA IGM
K993291 · LFX
DiaSorin, Inc.
Microbiology · 132d
Cleared Feb 10, 2000
YEASTEST
K993554 · JXB
Diagnostic Markers, Inc.
Microbiology · 113d
Cleared Feb 10, 2000
BACT/ALERT SV
K994343 · MDB
Organon Teknika Corp.
Microbiology · 49d