Home › Device types › DRS
Transducer, Blood-Pressure, Extravascular
FDA product code DRS · Class 2 · Cardiovascular
1,556
Registered devices
3,904
Adverse events
236
Recalls
148
510(k) clearances
Devices with this code
BIOTRANS™ Pressure Monitoring Kits — BIOPTIMAL INTERNATIONAL PTE. LTD.Medex — ICU MEDICAL, INC.Medex — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.BIOTRANS™ Pressure Monitoring Kits — BIOPTIMAL INTERNATIONAL PTE. LTD.N/A — UTAH MEDICAL PRODUCTS, INC.Medex — ICU MEDICAL, INC.Antmed — ShenZhen Antmed Co., LtdICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.Transpac™ — ICU MEDICAL, INC.Monitoring Kit — ARGON MEDICAL DEVICES, INC.Transpac™/Transtar™ — ICU MEDICAL, INC.Merit Medical® — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.Medex — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.BIOTRANS™ Pressure Monitoring Kits — BIOPTIMAL INTERNATIONAL PTE. LTD.ICU Medical — ICU MEDICAL, INC.BIOTRANS™ Pressure Monitoring Kits — BIOPTIMAL INTERNATIONAL PTE. LTD.Medex — ICU MEDICAL, INC.Arterial Line Kit — ARGON MEDICAL DEVICES, INC.NAMIC — NAVILYST MEDICAL, INC.NAMIC — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-24 | Medline Industries, LP | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 | Medline Industries, LP | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2025-02-12 | MEDLINE INDUSTRIES, LP - Northfield | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting sea |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting sea |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting sea |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting sea |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting sea |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting sea |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting sea |
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