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Plethysmograph, Impedance
FDA product code DSB · Class 2 · Cardiovascular
235
Registered devices
8
Adverse events
2
Recalls
115
510(k) clearances
Devices with this code
EV1000 — Edwards Lifesciences LLCEmpowerSync® Remote Control Pendant Switch — Bracco Injeneering SAReDS System — SENSIBLE MEDICAL INNOVATIONS LTDInjector — Bracco Injeneering SAStarling SV — CHEETAH MEDICAL (ISRAEL) LTDNA — GE Healthcare Finland OyPhysioFlow — MANATECPatient Monitor — Edan Instruments, Inc.Patient Monitor — Edan Instruments, Inc.HemoSphere Vita — Edwards Lifesciences LLCReDS System — SENSIBLE MEDICAL INNOVATIONS LTDFinapres — Finapres Medical Systems B.V.ReDS Wearabel System — SENSIBLE MEDICAL INNOVATIONS LTDZOLL Patch — ZOLL MANUFACTURING CORPORATIONHemoSphere — Edwards Lifesciences LLCEmpowerCTA®+ Injector System — Bracco Injeneering SAFinapres — Finapres Medical Systems B.V.CLEARSIGHT — Edwards Lifesciences LLCEV1000 — Edwards Lifesciences LLCViewfinder remote app — Edwards Lifesciences LLCReDS Wearable System — SENSIBLE MEDICAL INNOVATIONS LTDCARDIOTRONIC — Osypka Medical GmbHFinapres — Finapres Medical Systems B.V.Remote Control (Onyx) — Bracco Injeneering SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-02 | Baxter Healthcare Corporation | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. |
| 2015-12-01 | Partners In Medicine Llc | Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim per |
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