FDA Device Intelligence
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Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

FDA product code LPP · Class 2 · Anesthesiology

101
Registered devices
10
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2012-11-27Radiometer America IncRADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.

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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.