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"
49–72 of 112
Search insights Median review: 57d Cleared: 100% Top manufacturer: Hardy Diagnostics Lead specialty: Microbiology
Cleared Oct 25, 2000
HARDYDISK CEFUROXIME, 30MCG
K002656 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Oct 25, 2000
HARDYDISK STREPTOMYCIN, 300MCG
K002368 · JTN
Hardy Diagnostics
Microbiology · 83d
Cleared Oct 19, 2000
HARDYDISK NETILMICIN, 30MCG
K002663 · JTN
Hardy Diagnostics
Microbiology · 55d
Cleared Jul 27, 2000
HARDY DISK CLARITHROMYCIN, 15MCG
K001728 · JTN
Hardy Diagnostics
Microbiology · 50d
Cleared Jun 07, 2000
HARDYDISK CINOXACIN, 100 MCG
K001487 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Jun 01, 2000
HARDYDISK CEFONICID, 30 MCG
K001490 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared Jun 01, 2000
HARDYDISK CEFOPERAZONE, 75 MCG
K001489 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared Apr 13, 2000
HARDYDISK, CEPHALOTHIN 30MCG
K000526 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Apr 07, 2000
HARDYDISK OFLOXACIN 5MCG
K000525 · JTN
Hardy Diagnostics
Microbiology · 51d
Cleared Apr 07, 2000
HARDYDISK, CEFOTAXIME 30MCG
K000524 · JTN
Hardy Diagnostics
Microbiology · 51d
Cleared Apr 07, 2000
HARDYDISK, VANCOMYCIN 30MCG
K000509 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Apr 07, 2000
HARDYDISK CEFTRIAXONE 30MCG
K000440 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Apr 07, 2000
HARDYDISK, NITROFURANTOIN
K000272 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, SULFA/TRIMETH
K000271 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, AMPICILLIN, 10MCG
K000268 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
K000261 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Mar 31, 2000
HARDYDISK, CEFOXITIN, 30MCG
K000305 · JTN
Hardy Diagnostics
Microbiology · 59d
Cleared Mar 29, 2000
HARDYDISK, TETRACYCLINE 30MCG
K000304 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Mar 24, 2000
HARDY DISK, PENICILLIN, 10 UNITS
K000302 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Mar 21, 2000
HARDYDISK, CEFTAZIDIME, 30MCG
K000259 · JTN
Hardy Diagnostics
Microbiology · 53d
Cleared Mar 21, 2000
HARDYDISK, CIPROFLOXACIN, 5MCG
K000258 · JTN
Hardy Diagnostics
Microbiology · 53d
Cleared Mar 21, 2000
HARDYDISK, KANAMYCIN, 30MCG
K000203 · JTN
Hardy Diagnostics
Microbiology · 60d
Cleared Mar 02, 2000
HARDYDISK, CARBENICILLIN, 100MCG
K000181 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Mar 02, 2000
HARDYDISK TICARILLIN 75MCG
K000175 · JTN
Hardy Diagnostics
Microbiology · 42d