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Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
FDA product code CCQ · Class 1 · Anesthesiology
254
Registered devices
627
Adverse events
9
Recalls
62
510(k) clearances
Devices with this code
VixOne™ Nebulizer Kit — Canadian Hospital Specialties LimitedSalter AIRE Elite — SALTER LABSCuraplex — BOUND TREE MEDICAL, LLCShusher Care — PENO LLCN/A — SALTER LABSHUDSON RCI — TELEFLEX INCORPORATEDN/A — SALTER LABSN/A — SALTER LABSFOFO — Foshan Hongfeng Co., Ltd.LMA ATOMIZATION — TELEFLEX INCORPORATEDsilverfox — Silverfox Corporation LimitedN/A — SALTER LABSMedSource Nebulizer — MEDSOURCE INTERNATIONAL LLCN/A — SALTER LABSMedSource Nebulizer — MEDSOURCE INTERNATIONAL LLCLMA ATOMIZATION — TELEFLEX INCORPORATEDN/A — SALTER LABSCuraplex — BOUND TREE MEDICAL, LLCN/A — SALTER LABSsilverfox — Silverfox Corporation LimitedAincA® — ANESTHESIA ASSOCIATES, INC.Salter AIRE Elite — SALTER LABSOmron A.I.R.S.Disposable Nebulizer Kit — Omron Healthcare, Inc.N/A — SALTER LABS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2013-04-30 | Nephron Pharmaceuticals Corp. | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| 2013-04-30 | Nephron Pharmaceuticals Corp. | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| 2013-04-30 | Nephron Pharmaceuticals Corp. | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| 2011-03-25 | Salter Laboratories, Division of Regulatory Affairs | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respira |
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