Home › Device types › BYE
Attachment, Breathing, Positive End Expiratory Pressure
FDA product code BYE · Class 2 · Anesthesiology
783
Registered devices
254
Adverse events
10
Recalls
80
510(k) clearances
Devices with this code
02-RESQ — PULMODYNE INCFlow-Safe II EZ Disposable CPAP System — MERCURY ENTERPRISES, INC.O2-MAX — PULMODYNE INC02-MAX — PULMODYNE INCAirLife™ — AIRLIFE02-RESQ — PULMODYNE INCo_two CPAP — O-Two Medical Technologies IncInfant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITED02-MAX — PULMODYNE INCInfant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITEDAirLife™ — AIRLIFEInfant Resuscitator T-Piece Catheter Access Adapter — FLEXICARE MEDICAL LIMITEDVentlab — VENTLAB, LLCo_two CPAP — O-Two Medical Technologies IncDisposable PEEP 20 valve — Ambu A/SA-PEP — ENGINEERED MEDICAL SYSTEMS INCEmergent Respiratory — MDL Solutions IncorporatedAirLife — Carefusion CorporationO2-MAX — PULMODYNE INCFlow-Safe II Disposable CPAP System — MERCURY ENTERPRISES, INC.02-MAX — PULMODYNE INCCuraplex® — BOUND TREE MEDICAL, LLCAirLife™ — AIRLIFERUSCH — TELEFLEX INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-15 | Westmed, Inc. | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted |
| 2019-01-15 | Westmed, Inc. | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted |
| 2019-01-15 | Westmed, Inc. | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted |
| 2015-09-24 | Airways Development LLC | Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determin |
| 2008-03-04 | Smiths Medical ASD, Inc. | Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive |
| 2008-03-04 | Smiths Medical ASD, Inc. | Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive |
| 2007-08-21 | Ambu Incorporated | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. |
| 2007-08-21 | Ambu Incorporated | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. |
| 2007-08-21 | Ambu Incorporated | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. |
| 2007-08-21 | Ambu Incorporated | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. |
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