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Sign in to claim this brandMedisystems Corp.
US
Last updated May 23, 2026
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Catalogue (218)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Access Alert Gauge | K002372 | FDA 510(k) | Class II | Active |
| Medisystems Transducer Protector | K983076 | FDA 510(k) | Class II | Active |
| Reverso | K994306 | FDA 510(k) | Class II | Active |
| Medisystems Hemodialysis Fistula Set | K910734 | FDA 510(k) | Class II | Active |
| Medisystems Needles & Syringes | K812910 | FDA 510(k) | Class II | Active |
| Medisystem Negative Pressure | K811839 | FDA 510(k) | Class II | Active |
| Medisystems Fistula Needle | K811838 | FDA 510(k) | Class II | Active |
| Kf-E Series Hollow Fiber Dialyzer | K823069 | FDA 510(k) | Class II | Active |
| Medisystems Pheresis Needle | K862002 | FDA 510(k) | Class II | Active |
| Medisystems Anti-Stick Injection Site Needle | K910733 | FDA 510(k) | Class II | Active |
| Medisystems Fistula Needles | K823068 | FDA 510(k) | Class II | Active |
| Arterial Venous Blood Tubing Set | K953823 | FDA 510(k) | Class II | Active |
| Medisystems Peritoneal Dialysis Sets | K963668 | FDA 510(k) | Class II | Active |
| Medisystems Luer Access Injection Site | K010279 | FDA 510(k) | Class II | Active |
| Kf-E Series Of Hollow Fiber Dialyzers | K812353 | FDA 510(k) | Class II | Active |
| Medisystems Arterial-Venous Fistula Needle Set With Securement Device | K062953 | FDA 510(k) | Class II | Active |
| Medisystems Apheresis Needle With Guard | K932074 | FDA 510(k) | Class II | Active |
| Medisystems Dialysis Priming Sets | K971860 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 31, 2012 | Z-1126-2012 | — | terminated | Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle |