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"
25–48 of 112
Search insights Median review: 57d Cleared: 100% Top manufacturer: Hardy Diagnostics Lead specialty: Microbiology
Cleared Nov 15, 2016
HardyCHROM ESBL
K160512 · JSO
Hardy Diagnostics
Microbiology · 265d
Cleared Nov 24, 2015
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
K152846 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Nov 24, 2015
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
K152838 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared May 04, 2011
HARDYCHROM MRSA
K102922 · JSO
Hardy Diagnostics
Microbiology · 215d
Cleared Dec 17, 2010
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
K103538 · JTN
Hardy Diagnostics
Microbiology · 15d
Cleared Jan 08, 2010
HARDYDISK AST TELAVANCIN,30UG
K093807 · JTN
Hardy Diagnostics
Microbiology · 28d
Cleared Jan 29, 2008
HARDYDISK AST DORIPENEM 10 UG
K080019 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Aug 23, 2006
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
K062245 · JTN
Hardy Diagnostics
Microbiology · 21d
Cleared Jun 13, 2001
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
K011384 · JTN
Hardy Diagnostics
Microbiology · 37d
Cleared May 18, 2001
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · JTN
Hardy Diagnostics
Microbiology · 11d
Cleared Apr 26, 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · JTN
Hardy Diagnostics
Microbiology · 16d
Cleared Jan 25, 2001
HARDYDISK SULFISOXAZOLE
K003690 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Jan 19, 2001
HARDYDISK TRIMETHOPRIM 5MCG
K003554 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Jan 17, 2001
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
K003556 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Jan 12, 2001
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
K003686 · JTN
Hardy Diagnostics
Microbiology · 43d
Cleared Jan 12, 2001
HARDYDISK RIFAMPIN, 5MCG
K003537 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK NAFCILLIN, 1 MCG
K003536 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Dec 13, 2000
HARDY DISK, CEFPODOXINE, 10MCG
K003532 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Nov 02, 2000
HARDYDISK CLINDAMYCIN, 2MCG
K002662 · JTN
Hardy Diagnostics
Microbiology · 69d
Cleared Oct 26, 2000
HARDYDISK LEVOFLOXACIN, 5MCG
K002664 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK CEFOTETAN, 30MCG
K002661 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK LOMEFLOXACIN, 10MCG
K002660 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK GENTAMICIN, 120MCG
K002369 · JTN
Hardy Diagnostics
Microbiology · 84d
Cleared Oct 26, 2000
HARDY DISK CEFTIZOXIME, 30MCG
K002367 · JTN
Hardy Diagnostics
Microbiology · 84d