Medical device manufacturer
Isle Media and Sterile Products, Inc.
Isle Media and Sterile Products, Inc. holds 93 FDA 510(k) clearances across 12 product codes. Median elapsed review time is 29 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 93
- Product codes
- 12
- Median review
- 29 days
- Recall records
- 0
How does FDA spell Isle Media and Sterile Products, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Isle Media and Sterile Products, Inc. file in?
12 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | 17 | 29 days | |
| JSJ | Culture Media, Selective And Non-Differential | 17 | 20 days | |
| JSG | Culture Media, Non-Selective And Non-Differential | 15 | 29 days | |
| JSI | Culture Media, Selective And Differential | 15 | 23 days | |
| JSC | Culture Media, General Nutrient Broth | 6 | 22 days | |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 5 | 29 days | |
| JSD | Culture Media, Selective Broth | 4 | 23 days | |
| JSM | Culture Media, Non-Propagating Transport | 4 | 14 days | |
| JSE | Culture Media, Multiple Biochemical Test | 3 | 30 days | |
| JSF | Culture Media, Single Biochemical Test | 3 | 39 days | |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 3 | 20 days | |
| JSR | Kit, Identification, Dermatophyte | 1 | 38 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 Isle Media and Sterile Products, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Isle Media and Sterile Products, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K831671 | MODIFIED SOYBEAN CASEIN DIGEST BROTH | JSG | 66 | |
| K821218 | CAMPY-S AGAR | JSJ | 17 | |
| K820863 | MEDIA FOR IN-VITRO DIAGNOSTIC USE | JSJ | 18 | |
| K812798 | MOTILITY GI MEDIUM | JSG | 14 | |
| K812797 | SCHAEDLER AGARS | JSG | 14 | |
| K812796 | ANAEROBIC CNA BLOOD AGAR | JSJ | 14 | |
| K812795 | ANAEROBIC BLOOD AGAR | JSG | 14 | |
| K800818 | CHLAMYDOSPORE AGAR | JSH | 13 | |
| K800807 | CORN MEAL AGAR MEDIA | JSJ | 14 | |
| K800334 | MARTIN-LEWIS AGAR | JTY | 18 |
Source: openFDA device/510k · retrieved
Watch what Isle Media and Sterile Products, Inc. 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.