FDA Device Intelligence
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Spirometer, Therapeutic (Incentive)

FDA product code BWF · Class 2 · Anesthesiology

200
Registered devices
192
Adverse events
1
Recalls
108
510(k) clearances

Devices with this code

vPEP — D R BURTON HEALTHCARE, LLCAerosure — ACTEGY LIMITEDPortex — ICU MEDICAL, INC.HUDSON RCI — TELEFLEX INCORPORATEDOxyPAP PAP DEVICE w/o MANOMETER — D R BURTON HEALTHCARE, LLCAirLife™ — AIRLIFEAirLife™ — SUNMED, LLCMaxiPEP — ENCHANT TEK. CO, LTD.AirLife — Carefusion CorporationPortex — ICU MEDICAL, INC.Lung Flute® for Home Care — MEDICAL ACOUSTICS LLCAIM — VITALOGRAPH (IRELAND) LIMITEDMedline — MEDLINE INDUSTRIES, INC.AEROBIKA Oscillating Positive Expiratory Pressure Therapy System — Trudell Medical InternationalOxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETER — D R BURTON HEALTHCARE, LLCPortex — ICU MEDICAL, INC.The Breather — Pn Medical IncHUDSON RCI — TELEFLEX INCORPORATEDPortex — ICU MEDICAL, INC.Portex — ICU MEDICAL, INC.The Breather — Pn Medical IncAEROBIKA OPEP with Manometer — Trudell Medical InternationalAIM — VITALOGRAPH (IRELAND) LIMITEDHUDSON RCI — TELEFLEX INCORPORATED

Recent recalls

DateFirmReason
2020-12-21Smiths Medical ASD Inc.Shipping box may contain wrong model.

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