Home › Device types › CAF
Nebulizer (Direct Patient Interface)
FDA product code CAF · Class 2 · Anesthesiology
2,489
Registered devices
3,267
Adverse events
36
Recalls
509
510(k) clearances
Devices with this code
I-neb — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTDMISTIC — PEGASUS RESEARCH CORPORATIONAireHealth Nebulizer — AIREHEALTH LLCVentlab — VENTLAB, LLCNebulizer Mask — SUNSET HEALTHCARE SOLUTIONS, INC.Sami the Seal — VEGA TECHNOLOGIES INC.MICRO CIRRUS SMALL PARTICLE NEB — Intersurgical IncorporatedMini-Heart® Continuous Nebulizer — WESTMED, INC.Redrock — Drive Devilbiss HealthcareAerogen® Solo Nebulizer System — AEROGEN LIMITEDDeVilbiss — DEVILBISS HEALTHCARE LLCHUDSON RCI — TELEFLEX INCORPORATEDDRIVEMEDICAL — Drive Devilbiss HealthcareHailie Sensor - for use only with Advair HFA — ADHERIUM (NZ) LIMITEDSideStream — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTDN/A — SALTER LABSDRIVEMEDICAL — Drive Devilbiss HealthcareAirLife™ — VYAIRE MEDICAL, INC.HUDSON RCI — TELEFLEX INCORPORATEDCURAPLEX — PEGASUS RESEARCH CORPORATIONHUDSON RCI — TELEFLEX INCORPORATEDPortex — ICU MEDICAL, INC.CURAPLEX — PEGASUS RESEARCH CORPORATIONVixOne — WESTMED, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-04 | MEDLINE INDUSTRIES, LP - Northfield | Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers. |
| 2021-03-31 | Smiths Medical ASD Inc. | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. |
| 2018-08-29 | SANRAI INTERNATIONAL LLC | The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
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