Indianaola, PA, US · 4 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PQH | Iodinated Contrast Media Transfer Tubing Set | Class II | General Hospital | 2 | 2026-06-12 |
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | 1 | 2026-02-13 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | 1 | 2025-09-04 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-11-30 | Class II | Ongoing | Z-0910-2023 | Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affec… | — | Black specks may be present on the packaged needles |
| 2021-09-14 | Class II | Terminated | Z-0199-2022 | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate materi… | — | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) |
| 2020-10-05 | Class II | Terminated | Z-0483-2021 | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS … | — | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-12 | K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | PQH | Class II | General Hospital |
| 2026-02-13 | K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | DXT | Class II | Cardiovascular |
| 2025-09-04 | K250893 | Ball Joint Guide Array (66295) | HAW | Class II | Neurology |
| 2020-07-30 | K200280 | MEDRAD Imaging Bulk Package Transfer Spike | PQH | Class II | General Hospital |