FDA Device Intelligence
HomeHYGIA HEALTH SERVICES, INC. › Nellcor

Nellcor

HYGIA HEALTH SERVICES, INC. · Model MAX-I · UDI-DI 10817357020141

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

Description

Nellcor OxiMax Infant Pulse Oximeter Sensor

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.

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.