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Starling

CHEETAH MEDICAL (ISRAEL) LTD · Model CMMST5S · UDI-DI 07290013030290

DSBDQADXN Prescription
10
510(k) clearances
8
Adverse events
2
Recalls
66
Facilities

Description

The Starling Monitor provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function, as well as blood pressure parameters and blood oxygen saturation levels.

Recalls

DateFirmReason
2022-09-02Baxter Healthcare CorporationLabeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
2015-12-01Partners In Medicine LlcDevice non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.