Medical device manufacturer
Hardy Media Inc Dba Hardy Diag
Hardy Media Inc Dba Hardy Diag holds 114 FDA 510(k) clearances across 12 product codes. Median elapsed review time is 49 days. openFDA lists 4 recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 114
- Product codes
- 12
- Median review
- 49 days
- Recall records
- 4
How does FDA spell Hardy Media Inc Dba Hardy Diag?
FDA publishes this company under 2 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Hardy Media | device/510k | normalised |
| Hardy Media Inc Dba Hardy Diag | device/recall | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Hardy Media Inc Dba Hardy Diag file in?
12 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 26 | 49 days | |
| JSF | Culture Media, Single Biochemical Test | 20 | 84 days | |
| JSI | Culture Media, Selective And Differential | 17 | 60 days | |
| JSG | Culture Media, Non-Selective And Non-Differential | 13 | 35 days | |
| KZI | Culture Media, Enriched | 9 | 84 days | |
| JSE | Culture Media, Multiple Biochemical Test | 7 | 28 days | |
| JSH | Culture Media, Non-Selective And Differential | 7 | 60 days | |
| JSC | Culture Media, General Nutrient Broth | 5 | 47 days | |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 5 | 39 days | |
| JSM | Culture Media, Non-Propagating Transport | 2 | 35 days | |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 | 23 days | |
| JSD | Culture Media, Selective Broth | 1 | 84 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Hardy Media Inc Dba Hardy Diag had a recall?
openFDA lists 4 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0078-2007TerminatedGMZ
Performance failure; the product is failing to show pigment development for E. coli 0157.
Z-1451-06TerminatedJSO
This recall is being conducted due to the performance failure nearing the end of the product shelf life.
Z-0542-04TerminatedJTO
Mislabeled.
Z-1076-03Terminated
Customers complained of bacterial contamination of lot A10-3155A.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Hardy Media Inc Dba Hardy Diag cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K880134 | MIDDLEBROOK 7H11 AGAR | KZI | 85 | |
| K880133 | MIL MEDIUM | JSE | 85 | |
| K880131 | LOWENSTEIN-JENSEN, GRUFT | KZI | 85 | |
| K880126 | LAURYL TRYPTOSE BROTH | JSF | 85 | |
| K880125 | LOWENSTEIN-JENSEN, SELECTIVE | JSI | 85 | |
| K880124 | LOWENSTEIN-JENSEN, W/NACL | JSJ | 85 | |
| K880123 | LOWENSTEIN-JENSEN SLANT | JSJ | 85 | |
| K880122 | MIDDLEBROOK 7H9 BROTH | KZI | 85 | |
| K880121 | MOELLERS DECARBOXYLASE, BASE | JSH | 85 | |
| K880120 | MOELLERS DECARBOXYLASE, LYSINE | JSF | 85 |
Source: openFDA device/510k · retrieved
Watch what Hardy Media Inc Dba Hardy Diag files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.