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Analyzer, Gas, Oxygen, Gaseous-Phase
FDA product code CCL · Class 2 · Anesthesiology
667
Registered devices
72
Adverse events
5
Recalls
122
510(k) clearances
Devices with this code
NA — GE Healthcare Finland OyCARESCAPE B850 — GE Healthcare Finland OyMiniOX — OHIO MEDICAL, LLCVital Signs™ — AirLife Finland OyMAX-49 — MAXTEC, LLCMax-13 Oxygen Sensor — MAXTEC, LLCSensoronics — SENSORONICS INCORPORATEDNA — GE Healthcare Finland OyPatient Monitor — Edan Instruments, Inc.6050-0004-110 — Honeywell Healthcare Solutions GmbHOxygen Sensor — Honeywell Healthcare Solutions GmbHTeledyne Analytical Instruments — Teledyne Analytical InstrsO2-Sensor — IT Dr. Gambert GmbHAnalytical Industries Inc. — ANALYTICAL INDUSTRIES INC.O2-Sensor — IT Dr. Gambert GmbHNA — GE Healthcare Finland OyMOX9 — CITY TECHNOLOGY LIMITEDMAXVENTURI — MAXTEC, LLCMax-14 Oxygen Sensor — MAXTEC, LLCBIRD SENTRY2 — Carefusion CorporationVital Signs — Carefusion Finland 320 OyO2-Sensor — IT Dr. Gambert GmbHNOxBOXi — NOXBOX LTDOxygen Sensor — Honeywell Healthcare Solutions GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-24 | GE Healthcare | A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C |
| 2014-08-08 | GE Healthcare, LLC | GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules |
| 2014-05-23 | GE Healthcare, LLC | Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to p |
| 2009-11-25 | Teleflex Medical | Sensor causes the oxygen monitor to display prematurely a Low Sensor warning which indicates an early maintenance requirement for the instrument. This may resul |
| 2003-10-27 | Teledyne Analytical Instruments | Potential failure to display the battery low light to the end-user. |
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