ClearanceBrief
Panels › Anesthesiology › Product code CAF · Class 2

Nebulizer (Direct Patient Interface)

Regulation 868.5630

4510(k)s in 12 months (509 all time)
0recalls in 12 months (36 all time)
25recalls that name a 510(k)
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Top companies in CAF

Company510(k)sRecalls
Airlife, Inc.160
Aerogen Limited94
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company013
Vortran Medical Technology 1, Inc.120
Salter Labs92
Thayer Medical Corp.92
Adherium (Nz), Ltd.100
Reciprocal Labs100
Omron Healthcare, Inc.71
Pari Innovative Manufacturers, Inc.80
Decided510(k)Device and applicantCode
Dec 30, 1976K761299DISPOSABLE NEBULIZER
Mcgaw Respiratory Therapy
CAF
Dec 30, 1976K761298PRE-FILLED DISPOSABLE NEBULIZER
Mcgaw Respiratory Therapy
CAF
Dec 9, 1976K760964ADDI-MIST
Respiratory Care, Inc.
CAF
Oct 27, 1976K760845SOLO-SPHERE HEATER
Respiratory Therapy
CAF
Oct 15, 1976K760585U-MID PREFILLED NEBULIZER
Bd Becton Dickinson Vacutainer Systems Preanalytic
CAF
Sep 3, 1976K760489NEBULIZER, HANDHELD (T UP-DRAFT)
Hudson Oxygen Therapy Sales Co.
CAF
Aug 26, 1976K760442NEBULIZER ADAPTER (AERMIST)
Aerway Laboratories, Inc.
CAF
Aug 11, 1976K760335NEBULIZER, MICRO (ADDI-MIST)
Respiratory Care, Inc.
CAF
Jul 20, 1976K760095RESPIRIZOR
Campillary Systems
CAF

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