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Nellcor

Covidien LP · Model MAXAR · UDI-DI 20884522040102

NLF Prescription
1
510(k) clearances
89
Adverse events
3
Recalls
19
Facilities

Description

Adult SpO2 Sensor Remanufactured;Reprocessed device for single use. Reprocessed by Covidien llc.

Recalls

DateFirmReason
2008-03-11Ascent Healthcare Solutions, Inc.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
2008-03-11Ascent Healthcare Solutions, Inc.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
2008-03-11Ascent Healthcare Solutions, Inc.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

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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.