Scopis GmbH
2 clearances · aggregated across 2 source records
Scorecard
Events per device across the 23-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
23 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Calibration body EM | 1.0 | PGW | B057U1038020 | 0 |
| Endoscope tracker EM | 1.0 | PGW | B057U1037020 | 0 |
| Field generator mounting arm | 1.0 | PGW | B057U3011010 | 0 |
| Field generator planar | 1.0 | PGW | B057U3010010 | 0 |
| Hybrid Navigation Unit EM | 2.2 | PGW | B057U2040040 | 0 |
| Instrument clamp 10-16 mm | 1.0 | PGW | B057U1017050 | 0 |
| Instrument clamp 2-6 mm | 1.0 | PGW | B057U1017010 | 0 |
| Instrument clamp 6-10 mm | 1.0 | PGW | B057U1017030 | 0 |
| Instrument clamp forceps | 1.0 | PGW | B057U1017020 | 0 |
| Instrument clip 4 mm | 1.0 | PGW | B057U1085400 | 0 |
| Instrument port | 1.0 | PGW | B057U1049010 | 0 |
| NOVA AR | 2.6.15 | PGW | B057U40030 | 0 |
| NOVA AR | 2.6.16 | PGW | B057U4003260160 | 0 |
| NOVA AR | 2.6.17 | PGW | B057U4003260170 | 0 |
| NOVA Basic | 2.6.8 | PGW | B057U40140 | 0 |
| Patient tracker EM mini | 1.0 | PGW | B057U1031120 | 0 |
| Patient tracker EM-D mini | 1.0 | PGW | B057U1031300 | 0 |
| Patient tracker tabs (PU 100) | 1.0 | PGW | B057U9020010 | 0 |
| Precision Pointer EM | 1.0 | PGW | B057U1029010 | 0 |
| Registration pointer EM-D | 1.0 | PGW | B057U1029030 | 0 |
| Suction tube Eicken EM | 1.0 | PGW | B057U1030120 | 0 |
| Suction tube Frazier EM | 1.0 | PGW | B057U1030110 | 0 |
| Universal Tracker EM | 1.0 | PGW | B057U1046020 | 0 |
Facilities
Registered establishments with their latest FDA inspection outcome.
No registered facilities linked.