FDA Device Intelligence
HomeMASIMO CORPORATION › RD Sedline

RD Sedline

MASIMO CORPORATION · Model 4298 · UDI-DI 00843997012485

OLW Prescription
10
510(k) clearances
347
Adverse events (1 deaths)
1
Recalls
36
Facilities

Description

RD Sedline Patient Cable

Recalls

DateFirmReason
2018-07-26Covidien LLCRevised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.