Scorecard
Events per device across the 419-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
419 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|
| Arie Full Face Vented Mask Kit | 50851 | BZD | 00814747024744 | 1 |
| Arie Full Face Vented Mask, Large | 50806 | BZD | 00814747024737 | 1 |
| Arie Full Face Vented Mask, Medium | 50805 | BZD | 00814747024720 | 1 |
| Innova Full Face Vented Mask, Large | 50854 | BZD | 00814747021866 | 1 |
| Innova Full Face Vented Mask, Medium | 50853 | BZD | 00814747021859 | 1 |
| Innova Full Face Vented Mask, Small | 50852 | BZD | 00814747021842 | 1 |
| Innova Nasal Non Vented Mask, S/M | 50592 | BZD | 00814747022610 | 1 |
| Innova Nasal Non Vented Mask, m/l | 50593 | BZD | 00814747022627 | 1 |
| Innova Nasal Vented Mask, m/l | 50163 | BZD | 00814747021880 | 1 |
| Innova Nasal Vented Mask, s/m | 50162 | BZD | 00814747021873 | 1 |
| Mojo Full Face Mask, Large with Headgear | 50837 | BZD | 00814747023945 | 1 |
| Mojo Full Face Mask, Medium with Headgear | 50836 | BZD | 00814747023938 | 1 |
| Mojo Full Face Mask, Small with Headgear | 50835 | BZD | 00814747023921 | 1 |
| "iQ Blue Nasal Mask & 6"" Tapered Tubing " | 50293 | BZD | 00814747020760 | 0 |
| "iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ 3 Point Headgear" | 50250 | BZD | 00814747022849 | 0 |
| "iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ 3 Point Headgear" | 50250 | BZD | 00814747020746 | 0 |
| "iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ StableFit Headgear" | 50255 | BZD | 00814747020753 | 0 |
| "iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ StableFit Headgear" | 50255 | BZD | 00814747020876 | 0 |
| "iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ StableFit Headgear" | 50255 | BZD | 00814747022887 | 0 |
| Arie Full Face Vented Mask Kit | | | | 0 |
| Arie Full Face Vented Mask, Large | | | | 0 |
| Arie Full Face Vented Mask, Medium | | | | 0 |
| Arie Full Face Vented Mask, Small | 50804 | BZD | 00814747024713 | 0 |
| Arie Nasal Vented Mask Kit | 50194 | BZD | 00814747024706 | 0 |
| Arie Nasal Vented Mask, Large | 50151 | BZD | 00814747024690 | 0 |
| Arie Nasal Vented Mask, Medium | 50150 | BZD | 00814747024683 | 0 |
| Arie Nasal Vented Mask, Small | 50149 | BZD | 00814747024676 | 0 |
| Ascend Full Face Airgel Cushion, Large | 50209 | BZD | 00814747022528 | 0 |
| Ascend Full Face Airgel Cushion, Medium | 50208 | BZD | 00814747022511 | 0 |
| Ascend Full Face Airgel Cushion, Small | 50207 | BZD | 00814747020265 | 0 |
Showing 1–30 of 419Next → Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|
| 1222088 | SLEEPNET CORPORATION | Hampton, NH, US | NAI | |