Fiagon GmbH
16 clearances · 4 inspections · 1 adverse events · aggregated across 4 source records
Scorecard
Events per device across the 87-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
87 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| 4K Navigation Unit Cube4D | E011106-4K/8 | PGW | 04260759930157 | 1 |
| Adapter for Clipsensor | N011959 | OLO | 04260759930089 | 1 |
| Adapter for Flexsensor | N011949 | OLO | 04260759930072 | 1 |
| BiopsyPointer 190 | 1 | HAW | EFIAN012050CUS1 | 1 |
| BiopsyPointer 250 | 1 | HAW | EFIAN012051CUS1 | 1 |
| FlexPointer 1.5 | 1 | PGW | EFIAE0120041 | 1 |
| FlexPointer 1.5 mm | E012004 | PGW | 04260759930317 | 1 |
| FlexPointer 1.5 single use | 1 | PGW | EFIAE0130041 | 1 |
| FlexTube 3 single use | 1 | PGW | EFIAE0131041 | 1 |
| Localizer Adhesive pad Cranial | 1 | HAW | EFIAE012202CUS1 | 1 |
| Localizer Bone Anchor | 1 | HAW | EFIAE0122041 | 1 |
| Localizer K-Wire | N012213-RW | OLO | 04260759930027 | 1 |
| MapperBridge | N012701-RW | OLO | 04260759930034 | 1 |
| MultiPad | A011406-RW | OLO | 04260759930041 | 1 |
| Navigation Sensor Flexarm | N011012 | OLO | 04260759930010 | 1 |
| Navigation Unit Cube4D | E011106-HD/8 | PGW | 04260759930133 | 1 |
| PointerShell LS | 1 | PGW | EFIAE0129061 | 1 |
| PointerShell Universal | E012904 | PGW | 04260759930393 | 1 |
| PointerShell Universal | 1 | PGW | EFIAE0129041 | 1 |
| PointerTube Keat | E012107 | PGW | 04260759930348 | 1 |
| PointerTube Keat | 1 | PGW | EFIAE0121071 | 1 |
| PointerTube Kennedy | E012108 | PGW | 04260759930355 | 1 |
| PointerTube Kennedy | 1 | PGW | EFIAE0121081 | 1 |
| RIWOtrack Clipsensor | N012951 | OLO | 04260759930102 | 1 |
| RIWOtrack Cube4D | E011106-4K/8 RW | OLO | 04260759930058 | 1 |
| RIWOtrack Cube4D | E011106-HD/8 RW | OLO | 04260759931567 | 1 |
| RIWOtrack Flexsensor | N012950 | OLO | 04260759930096 | 1 |
| ShuntPointer | 1 | HAW | EFIAN012060CUS1 | 1 |
| VenSure Balloon Sinus Dilation System | 1 | LRC | EFIAE0135061 | 1 |
| VenSure Nav Balloon Sinus Dilation System | 1 | LRC | EFIAE0135161 | 1 |
Showing 1–30 of 87Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3010313588 | Fiagon GMBH | Hennigsdorf Brandenburg, DE | NAI |