Hardy Diagnostics
Hardy Diagnostics holds FDA 510(k) medical device clearances, first cleared 1993, most recent 2026, with 20 FDA device recalls on record.
Top product codes for Hardy Diagnostics
FDA recalls by Hardy Diagnostics
10 most recent of 20- Z-2887-2026 — HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,
- Z-2041-2025 — HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
- Z-1835-2021 — Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
- Z-0919-2021 — Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
- Z-0655-2021 — Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
- Z-0441-2021 — Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
- Z-2298-2020 — HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206
- Z-2146-2016 — QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
- Z-1571-2016 — Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
- Z-0470-2016 — FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hardy Diagnostics
1–100 of 110- K262113 — HardyDisk AST Tebipenem 10µg (TBP10)
- K260842 — HardyDisk AST Gepotidacin 10µg (GEP10)
- K253105 — HardyDisk AST Cefiderocol 30µg (FDC30)
- K250956 — HardyDisk AST Gepotidacin 10µg (GEP10)
- K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
- K233534 — Viral Transport Medium
- K241060 — HardyDisk AST Cefiderocol 30µg (FDC30)
- K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
- K230827 — HardyDisk AST Rezafungin 5µg (RZF5)
- K193504 — HardyDisk AST Cefiderocol 30ug (FDC30)
- K192326 — HardyDisk AST Lefamulin 20µg (LMU20)
- K191931 — HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
- K190553 — HardyCHROM CRE
- K183298 — HardyDisk AST Omadacycline 30µg (OMC30)
- K182357 — HardyDisk AST Eravacycline 20µg (ERV20)
- K181700 — HardyDisk AST Plazomicin 30ug (PLZ30)
- K173903 — Granada Medium
- K172621 — HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
- K171975 — HardyDisk AST Delafloxacin 5 µg (DLX5)
- K170586 — Strep B Carrot Broth One-Step
- K170481 — Strep B Carrot Broth Kit
- K170127 — HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
- K160512 — HardyCHROM ESBL
- K152838 — HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
- K152846 — HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
- K102922 — HARDYCHROM MRSA
- K103538 — HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
- K093807 — HARDYDISK AST TELAVANCIN,30UG
- K080019 — HARDYDISK AST DORIPENEM 10 UG
- K062245 — HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
- K011384 — HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
- K011385 — HARDKYDISK NEOMYCIN, 30 MCG
- K011086 — HARDYDISK BACITRACIN, 10MCG, MODEL Z927
- K003690 — HARDYDISK SULFISOXAZOLE
- K003554 — HARDYDISK TRIMETHOPRIM 5MCG
- K003556 — HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
- K003536 — HARDYDISK NAFCILLIN, 1 MCG
- K003537 — HARDYDISK RIFAMPIN, 5MCG
- K003686 — HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
- K003532 — HARDY DISK, CEFPODOXINE, 10MCG
- K002662 — HARDYDISK CLINDAMYCIN, 2MCG
- K002367 — HARDY DISK CEFTIZOXIME, 30MCG
- K002369 — HARDYDISK GENTAMICIN, 120MCG
- K002660 — HARDYDISK LOMEFLOXACIN, 10MCG
- K002661 — HARDYDISK CEFOTETAN, 30MCG
- K002664 — HARDYDISK LEVOFLOXACIN, 5MCG
- K002368 — HARDYDISK STREPTOMYCIN, 300MCG
- K002656 — HARDYDISK CEFUROXIME, 30MCG
- K002663 — HARDYDISK NETILMICIN, 30MCG
- K001728 — HARDY DISK CLARITHROMYCIN, 15MCG
- K001487 — HARDYDISK CINOXACIN, 100 MCG
- K001489 — HARDYDISK CEFOPERAZONE, 75 MCG
- K001490 — HARDYDISK CEFONICID, 30 MCG
- K000526 — HARDYDISK, CEPHALOTHIN 30MCG
- K000261 — HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
- K000268 — HARDYDISK, AMPICILLIN, 10MCG
- K000271 — HARDYDISK, SULFA/TRIMETH
- K000272 — HARDYDISK, NITROFURANTOIN
- K000440 — HARDYDISK CEFTRIAXONE 30MCG
- K000509 — HARDYDISK, VANCOMYCIN 30MCG
- K000524 — HARDYDISK, CEFOTAXIME 30MCG
- K000525 — HARDYDISK OFLOXACIN 5MCG
- K000305 — HARDYDISK, CEFOXITIN, 30MCG
- K000304 — HARDYDISK, TETRACYCLINE 30MCG
- K000302 — HARDY DISK, PENICILLIN, 10 UNITS
- K000203 — HARDYDISK, KANAMYCIN, 30MCG
- K000258 — HARDYDISK, CIPROFLOXACIN, 5MCG
- K000259 — HARDYDISK, CEFTAZIDIME, 30MCG
- K000175 — HARDYDISK TICARILLIN 75MCG
- K000181 — HARDYDISK, CARBENICILLIN, 100MCG
- K000130 — HARDYDISK, NALIDIXIC ACID, 30MCG
- K000182 — HARDYDISK TOBRAMYCIN, 10MCG
- K000201 — HARDYDISK, STREPTOMYCIN 10MCG
- K000183 — HARDYDISK, PIPERACILLIN, 100MCG
- K000128 — HARDYDISK, CEFAZOLIN, 30MCG
- K000022 — HARDYDISK CEFAMANDOLE, 30MCG
- K994134 — HARDYDISK OXACILLIN, 1MCG
- K994135 — HARDYDISK ERYTHROMYCIN, 15MCG
- K994150 — HARDYDISK NORFLOXACIN, 10MCG
- K994212 — HARDYDISK MEZLOCILLIN 75MCG
- K994089 — HARDYDISK CHLORAMPHENICOL, 30MCG
- K994091 — HARDYDISK GENTAMICIN, 10MCG
- K994129 — HARDYDISK CEFIXIME, 5MCG
- K994046 — HARDYDISK CEFACLOR 30MCG
- K994132 — HARDYDISK IMIPENEM, 10MCG
- K994063 — HARDYDISK AZTREONAM, 30MCG
- K994067 — HARDY DISK AMPICILLIN/SULBACTAM
- K994051 — HARDYDISK DOXYCYCLINE, 30MCG
- K993993 — HARDYDISK AMIKACIN 30MCG
- K993812 — CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
- K993994 — HARDYDISK AZITHROMYCIN 15MCG
- K964560 — BHI W/VANCOMYCIN AGAR
- K960075 — CHROMAGAR CANDIDA
- K955451 — CVM TRANSPORT
- K961191 — COLISCREEN
- K960996 — M. CAT BUTYRATE DISK
- K951754 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
- K941110 — PARAKIT
- K934331 — THAYER MARTIN, MODIFIED PILL POCKET
- K934330 — TRANSGROW
Data sourced from openFDA. This site is unofficial and independent of the FDA.