St. Paul, MN, US · 3 510(k) clearances · 4 PMAs · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2026-03-31 |
| NEU | Marker, Radiographic, Implantable | Class II | General, Plastic Surgery | 1 | 2025-07-23 |
| IYE | — | — | — | 1 | 2021-06-10 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-03-13 | P980053-S021 | Durasphere Injectable Bulking Agent | Normal 180 Day Track | LNM | Agent, Bulking, Injectable For Gastro-Urology Use | Unknown |
| 2024-01-18 | P980053-S020 | Durasphere® Injectable Bulking Agent | 30-Day Notice | LNM | Agent, Bulking, Injectable For Gastro-Urology Use | Unknown |
| 2022-10-27 | P980053-S019 | Durasphere Injectable Bulking Agent | 30-Day Notice | LNM | Agent, Bulking, Injectable For Gastro-Urology Use | Unknown |
| 2021-02-25 | P980053-S018 | Durasphere Injectable Bulking Agent | Normal 180 Day Track No User Fee | LNM | Agent, Bulking, Injectable For Gastro-Urology Use | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-07-26 | Class III | Ongoing | Z-3161-2024 | BiomarC EX Fiducial Marker System, Catalog Number 040165 | — | This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient. |
| 2022-12-16 | Class II | Terminated | Z-1041-2023 | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 | — | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, … |