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 |
|---|
| "Smart Control Sterile Cover for Remote Control VB10 ""VB10-SC""" | VB10-SC | PUI | 04260462742917 | 0 |
| "Steile Drape for ""CONTROL SCREEN""" | 12935.BUY0546 | PUI | 04260462743945 | 0 |
| "Steile Drape for ""Cart""" | 12935.BUY0887 | PUI | 04260462743907 | 0 |
| "Steile Drape for ""Surgical Arm""" | 12935.BUY0548 | PUI | 04260462743914 | 0 |
| "Sterile Cover for Remote Control Unit Drape Set ""VB10-RC""" | VB10-RC | PUI | 04260462743037 | 0 |
| "Sterile Drape for ""SCOUT ARM""" | 12935.BUY0549 | PUI | 04260462743853 | 0 |
| HMD cover set, consisting of 2 lens protective caps made of PP, color white | 12741.12365 | PUI | 04260462740524 | 0 |
| PEMICLIP - C-arm sterile cover set, widened frame cover with 6 clips PC3-SCSA-3 | PC3-SCSA-3 | PUI | 04260462742405 | 0 |
| PEMICLIP - C-arm sterile cover set, widened frame cover with 6 clips PC3-VB10-3 | PC3-VB10-3 | PUI | 04260462743006 | 0 |
| PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./oran | PC2-SD-3 | PUI | 04260462741279 | 0 |
| PEMIDrape - C-arm sterile cover set, metal temple cover blue line, Art.Nr. SP-CA | SP-CA-3 | PUI | 04260462742528 | 0 |
| PEMIDrape - C-arm sterile cover, metal temple cover blue line, Art.Nr. SP-CS-SD- | SP-CS-SD-3 | PUI | 04260462742467 | 0 |
| Sterile Disposable Button Cannula, 100 mm length | KK100L50S | GBX | 04260462742887 | 0 |
| Sterile Disposable Button Cannula, 100 mm length | KK100L150S | GBX | 04260462742900 | 0 |
| Sterile Disposable Button Cannula, 100 mm length | KK100L21S | GBX | 04260462742689 | 0 |
| Sterile Disposable Button Cannula, 45 mm length | KK45R21S | GBX | 04260462742825 | 0 |
| Sterile Disposable Button Cannula, 45 mm length | KK45R50S | GBX | 04260462742801 | 0 |
| Sterile Disposable Button Cannula, 45 mm length | KK45R150S | GBX | 04260462742788 | 0 |
| Sterile Disposable Button Cannula, 70 mm length | KK70L150S | GBX | 04260462742702 | 0 |
| Sterile Disposable Button Cannulas, 70 mm length | KK70L21S | GBX | 04260462742764 | 0 |
| Sterile Disposable Button Cannulas, 70 mm length | KK70L50S | GBX | 04260462742740 | 0 |
| Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm | 12741.12364 | PUI | 04260462740357 | 0 |
| Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm | 12741.13873 | PUI | 04260462742160 | 0 |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|
| 3017865161 | PEMAX KUNSTSTOFF GMBH | Stuttgart Baden-Wurttemberg, DE | — | |