Home › Device types › CAF
Nebulizer (Direct Patient Interface)
FDA product code CAF · Class 2 · Anesthesiology
2,475
Registered devices
2,847
Adverse events
36
Recalls
508
510(k) clearances
Devices with this code
Roscoe Medical — COMPASS HEALTH BRANDS CORP.MINISPACER — THAYER MEDICAL CORPORATIONAirLife — Carefusion CorporationProcure Nebulizer — PROACTIVE MEDICAL PRODUCTS, LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.Healthline, Medicator Maximizer, Methacholine — Medi/Nuclear Corporation, Inc.UnoMist™ Nebulizer Mask Kit — WESTMED, INC.Easy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONN/A — GaleMed Xiamen Co., Ltd.Aerogen® Professional Nebulizer System — AEROGEN LIMITEDAerogen® Professional Nebulizer System — AEROGEN LIMITEDB&F — Allied Medical, LLCHUDSON RCI — TELEFLEX INCORPORATEDHUDSON RCI — TELEFLEX INCORPORATEDNEBULIZER BOTTLE DISPOSABLE 6CC; OD:18mm — BESMED HEALTH BUSINESS CORP.Clever Choice — S.D.I. USA, INC.N/A — GALEMED CORPORATIONNucara Home — Drive Devilbiss HealthcareMaxineb Duo Filter Master Case — FLEXICARE MEDICAL LIMITEDKENOREX — KENTRON HEALTHCARE, INC.Trek S — PARI RESPIRATORY EQUIPMENT, INC.HUDSON RCI — TELEFLEX INCORPORATEDMini-HEART® — WESTMED, INC.AirLife — Carefusion Corporation
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.