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

112 results for "Hardy Diagnostics"
73–96 of 112
Search insights Median review: 57d Cleared: 100% Top manufacturer: Hardy Diagnostics Lead specialty: Microbiology
Cleared Feb 29, 2000
HARDYDISK, STREPTOMYCIN 10MCG
K000201 · JTN
Hardy Diagnostics
Microbiology · 39d
Cleared Feb 29, 2000
HARDYDISK TOBRAMYCIN, 10MCG
K000182 · JTN
Hardy Diagnostics
Microbiology · 40d
Cleared Feb 29, 2000
HARDYDISK, NALIDIXIC ACID, 30MCG
K000130 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Feb 28, 2000
HARDYDISK, PIPERACILLIN, 100MCG
K000183 · JTN
Hardy Diagnostics
Microbiology · 39d
Cleared Feb 18, 2000
HARDYDISK, CEFAZOLIN, 30MCG
K000128 · JTN
Hardy Diagnostics
Microbiology · 31d
Cleared Feb 17, 2000
HARDYDISK OXACILLIN, 1MCG
K994134 · JTN
Hardy Diagnostics
Microbiology · 72d
Cleared Feb 17, 2000
HARDYDISK CEFAMANDOLE, 30MCG
K000022 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Feb 16, 2000
HARDYDISK NORFLOXACIN, 10MCG
K994150 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 16, 2000
HARDYDISK ERYTHROMYCIN, 15MCG
K994135 · JTN
Hardy Diagnostics
Microbiology · 71d
Cleared Feb 15, 2000
HARDYDISK MEZLOCILLIN 75MCG
K994212 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Feb 11, 2000
HARDYDISK CEFIXIME, 5MCG
K994129 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared Feb 11, 2000
HARDYDISK GENTAMICIN, 10MCG
K994091 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 11, 2000
HARDYDISK CHLORAMPHENICOL, 30MCG
K994089 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 01, 2000
HARDYDISK CEFACLOR 30MCG
K994046 · JTN
Hardy Diagnostics
Microbiology · 64d
Cleared Jan 18, 2000
HARDYDISK IMIPENEM, 10MCG
K994132 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Jan 14, 2000
HARDY DISK AMPICILLIN/SULBACTAM
K994067 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Jan 14, 2000
HARDYDISK AZTREONAM, 30MCG
K994063 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Jan 10, 2000
HARDYDISK DOXYCYCLINE, 30MCG
K994051 · JTN
Hardy Diagnostics
Microbiology · 41d
Cleared Dec 27, 1999
HARDYDISK AMIKACIN 30MCG
K993993 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Dec 21, 1999
HARDYDISK AZITHROMYCIN 15MCG
K993994 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Dec 21, 1999
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL...
K993812 · JSM
Hardy Diagnostics
Microbiology · 41d
Cleared Jan 15, 1997
BHI W/VANCOMYCIN AGAR
K964560 · JSO
Hardy Diagnostics
Microbiology · 63d
Cleared Aug 02, 1996
CHROMAGAR CANDIDA
K960075 · JXC
Hardy Diagnostics
Microbiology · 204d
Cleared Jul 22, 1996
CVM TRANSPORT
K955451 · JSM
Hardy Diagnostics
Microbiology · 236d