BIOSEAL
13 adverse events · 10 recalls · 6 inspections · aggregated across 2 source records
Scorecard
Events per device across the 1,097-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.007 ▼
8 in the last 12 months
Higher volume than 87% 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
1,097 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Bioseal | 19711/10 | GAZ | 00630094197111 | 0 |
| Bioseal | 17326/20 | GAZ | 00630094173269 | 0 |
| Bioseal | 17336/10 | GAZ | 00630094173368 | 0 |
| Bioseal | 19704/50 | GAZ | 00630094197043 | 0 |
| Bioseal | 19718/12 | GAZ | 00630094197180 | 0 |
| Bioseal | 19703/50 | GAZ | 00630094197036 | 0 |
| Bioseal | 17323/20 | GAZ | 00630094173238 | 0 |
| Bioseal | 19701/50 | GAZ | 00630094197012 | 0 |
| Bioseal | 17321/20 | GAZ | 00630094173214 | 0 |
| Bioseal Inc. | 19718/20 | GCY | 00630094971827 | 0 |
| Bioseal Inc. | 19632D/25 | GCY | 00630094963242 | 0 |
| Bioseal Inc. | 19640/50 | GCY | 00630094964058 | 0 |
| Bioseal Inc. | 19605C/20 | GCY | 00630094960524 | 0 |
| Bioseal Inc. | 19602S/20 | GCY | 00630094960227 | 0 |
| Bioseal Inc. | 19737NS/50 | GCY | 00630094973753 | 0 |
| Bioseal Inc. | 19974/20 | KGS | 00630094997421 | 0 |
| Bioseal Inc. | 19652/20 | GCY | 00630094965222 | 0 |
| Bioseal Inc. | 18890/50 | KET | 00630094889054 | 0 |
| Bioseal Inc. | 19112/25 | ECI | 00630094911229 | 0 |
| Bioseal Inc. | 19684/50 | GCY | 00630094968452 | 0 |
| Bioseal Inc. | 18870/25 | KET | 00630094887029 | 0 |
| Bioseal Inc. | 28855/20 | KDC | 00630094885513 | 0 |
| Bioseal Inc. | 28854CS/10 | KDD | 00630094885414 | 0 |
| Bioseal Inc. | TQD076/20 | PUI | 00630094840765 | 0 |
| Bioseal Inc. | 19788NS/100 | GCY | 00630094788517 | 0 |
| Bioseal Inc. | 27-778B/20 | KDC | 00630094777825 | 0 |
| Bioseal Inc. | 27-774S/20 | KDC | 00630094777412 | 0 |
| Bioseal Inc. | 17751RG/50 | GCY | 00630094775166 | 0 |
| Bioseal Inc. | 17751/50 | GCY | 00630094775159 | 0 |
| Bioseal Inc. | 19920/20 | FMH | 00630094992020 | 0 |
Showing 1–30 of 1,097Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 2027062 | BIOSEAL | PLACENTIA, CA, US | VAI | |
| 3043620414 | Bioseal | Grapevine, TX, US | — |