Astura Medical
29 clearances · 22 adverse events · 2 inspections · aggregated across 2 source records
Scorecard
Events per device across the 14,678-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.000 →
5 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
14,678 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| SIRION | GB225510B | KWQ MAX OVD | 00840085225208 | 6 |
| OLYMPIC | ABBA00000 | KWP NKB OLO | 00841379176688 | 5 |
| OLYMPIC | ABAA00055 | MNH MNI OSH | 00841379131212 | 4 |
| DOLOMITE | LDB000006 | ODP OVE | 00840085232626 | 3 |
| DOLOMITE | LDD000006 | ODP OVE | 00840085250705 | 3 |
| HALF DOME | BH092409D | MAX | 00841379180876 | 3 |
| MASADA | NCAA00000 | KWP NKB OLO OWL | 00840085257636 | 3 |
| OLYMPIC | AARA75045 | MNH MNI OSH | 00841379124054 | 3 |
| OLYMPIC | AAPA75035 | MNH MNI OSH | 00841379122944 | 3 |
| OLYMPIC | AARA85055 | MNH MNI OSH | 00841379161219 | 3 |
| ZION | CA2000032 | KWQ | 00841379102496 | 3 |
| SIRION | GCDBAZZ08 | KWQ | 00840085229312 | 2 |
| ZION | CA3000048 | KWQ | 00841379102601 | 2 |
| ZION | CA1000014 | KWQ | 00841379102380 | 1 |
| ZION | CBAB40018 | KWQ | 00841379103820 | 1 |
| AFIBER | JBAC00025 | MQV | 00840085272301 | 0 |
| AFIBER | JBAC00050 | MQV | 00840085272318 | 0 |
| AFIBER | JBAC00150 | MQV | 00840085272332 | 0 |
| AFIBER | JBAC00100 | MQV | 00840085272325 | 0 |
| AFIBER | JBCB00050 | MQV | 00840085272349 | 0 |
| AFIBER | JBCB00100 | MQV | 00840085272356 | 0 |
| AFIBER | JBCB50205 | MQV | 00840085272363 | 0 |
| ALTA | DD161439C | PLR | 00841379184775 | 0 |
| ALTA | DD161419C | PLR | 00841379184577 | 0 |
| ALTA | DD141244C | PLR | 00841379184461 | 0 |
| ALTA | DD181523C | PLR | 00841379184973 | 0 |
| ALTA | DD161440C | PLR | 00841379184782 | 0 |
| ALTA | DD161442C | PLR | 00841379184805 | 0 |
| ALTA | DD161441C | PLR | 00841379184799 | 0 |
| ALTA | DD181526C | PLR | 00841379185000 | 0 |
Showing 1–30 of 14,678Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3011764740 | Astura Medical | Irving, TX, US | VAI |