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"
1–24 of 112
Search insights Median review: 57d Cleared: 100% Top manufacturer: Hardy Diagnostics Lead specialty: Microbiology
Cleared Aug 20, 2026
HardyDisk AST Tebipenem 10µg (TBP10)
K262113 · JTN
Hardy Diagnostics
Microbiology · 58d
Cleared May 11, 2026
HardyDisk AST Gepotidacin 10µg (GEP10)
K260842 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Nov 20, 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
K253105 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jun 26, 2025
HardyDisk AST Gepotidacin 10µg (GEP10)
K250956 · JTN
Hardy Diagnostics
Microbiology · 87d
Cleared Jun 04, 2025
NG-Test® CTX-M MULTI
K243499 · PTJ
Ng Biotech
Microbiology · 204d
Cleared May 15, 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
K250454 · JTN
Hardy Diagnostics
Microbiology · 86d
Cleared Aug 02, 2024
Viral Transport Medium
K233534 · JSM
Hardy Diagnostics
Microbiology · 273d
Cleared Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
K241060 · JTN
Hardy Diagnostics
Microbiology · 91d
Cleared Jul 06, 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
K231568 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
K230827 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
K193504 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Oct 02, 2019
NG-Test CARBA 5
K191889 · PTJ
Ng Biotech
Microbiology · 79d
Cleared Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · JTN
Hardy Diagnostics
Microbiology · 23d
Cleared Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
K191931 · JTN
Hardy Diagnostics
Microbiology · 12d
Cleared Apr 29, 2019
HardyCHROM CRE
K190553 · JSO
Hardy Diagnostics
Microbiology · 55d
Cleared Jan 18, 2019
HardyDisk AST Omadacycline 30µg (OMC30)
K183298 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Sep 26, 2018
HardyDisk AST Eravacycline 20µg (ERV20)
K182357 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Jul 10, 2018
HardyDisk AST Plazomicin 30ug (PLZ30)
K181700 · JTN
Hardy Diagnostics
Microbiology · 13d
Cleared Mar 22, 2018
Granada Medium
K173903 · PQZ
Hardy Diagnostics
Microbiology · 90d
Cleared Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
K172621 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Aug 01, 2017
HardyDisk AST Delafloxacin 5 µg (DLX5)
K171975 · JTN
Hardy Diagnostics
Microbiology · 32d
Cleared May 22, 2017
Strep B Carrot Broth One-Step
K170586 · PQZ
Hardy Diagnostics
Microbiology · 83d
Cleared May 16, 2017
Strep B Carrot Broth Kit
K170481 · PQZ
Hardy Diagnostics
Microbiology · 89d
Cleared Mar 14, 2017
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
K170127 · JTN
Hardy Diagnostics
Microbiology · 60d