Nds Surgical Imaging LLC
10 inspections · 9 clearances · 1 adverse events · aggregated across 3 source records
Scorecard
Events per device across the 460-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
460 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Radiance | 90X0670 | KQM | 00851455007812 | 19 |
| Depuy Synthes | Evo4K220 | LMB | 00817613020543 | 10 |
| Depuy Synthes | Evo4K220 | LMB | 00817613020987 | 8 |
| Radiance | 90X0672 | KQM | 00851455007836 | 2 |
| Radiance | 90X0695 | KQM | 00818089021188 | 2 |
| Radiance | 90X0666 | KQM | 00851455007782 | 1 |
| 4Klear | 4KL100.6M | KQM | 00817613020536 | 0 |
| 4Klear | 4KL100.15M | KQM | 00817613020680 | 0 |
| 4Klear | 4KL100.3M | KQM | 00817613020826 | 0 |
| 4Klear | 4KL100.15M | KQM | 00817613020802 | 0 |
| 4Klear | 4KL100.6M | KQM | 00817613020833 | 0 |
| 4Klear | 4KL100.9M | KQM | 00817613020673 | 0 |
| 4Klear | 4KL100.3M | KQM | 00817613020666 | 0 |
| 4Klear | 4KL100.9M | KQM | 00817613020819 | 0 |
| 4Klearity | 4KR100 | LMB | 00817613020420 | 0 |
| 4Klearity | 4KR100 | LMB | 00817613020604 | 0 |
| 4Klearity | 4KR100 | LMB | 00817613020253 | 0 |
| 4Klearity | 4KR100 | LMB | 00817613020550 | 0 |
| 4Klearity | 4KR110 | LMB | 00817613021045 | 0 |
| 4Klearity | 4KR110 | LMB | 00817613020758 | 0 |
| 4Klearity | P-4KR100 | 00817613020130 | 0 | |
| 4Klearity | 4KR100 | LMB | 00817613020796 | 0 |
| 4Klearity | 4KR100 | LMB | 00817613020369 | 0 |
| 4Klearity | 4KR120 | LMB | 00817613020697 | 0 |
| 4Klearity | 4KR100 | LMB | 00817613021021 | 0 |
| 4Klearity | 4KR100 | LMB | 00817613021038 | 0 |
| CMS9000 | CMS9000 | LMB | 00817613020284 | 0 |
| CMS9000 | CMS9000 | LMB | 00817613021175 | 0 |
| CMS9000 | CMS9000 | LMB | 00817613021281 | 0 |
| CMS9000 | CMS9000 | LMB | 00817613020888 | 0 |
Showing 1–30 of 460Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3003301977 | NDS SURGICAL IMAGING, LLC. | Sarasota, FL, US | VAI | |
| 3014991167 | NDS Surgical Imaging, LLC | Ludwigsstadt Bavaria, DE | — |