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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

DateFirm and productCodeLinked 510(k)
Sep 14, 2023MEDLINE INDUSTRIES, LP - Northfield
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Open, Classified
CAFK142153
Mar 31, 2021Smiths Medical ASD Inc.
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.
Terminated
CAFK961973
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Medline Prefilled 550 ml Sterile
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex 5ml Normal Saline (0.9%) Unit Dose
Terminated
CAFK820227
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex Unit Dose 15 ml Normal Saline
Terminated
CAFK820227
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex Unit Dose 5 ml Normal Saline (0.9%)
Terminated
CAFK820227
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Medline Prefilled 350 ml Sterile
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex 500 ml Sterile Water USP Pour Bottle
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex 1000 ml Sterile Water USP Pour Bottle
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.
Terminated
CAFNone listed
Feb 4, 2019Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.
Terminated
CAFNone listed
Aug 29, 2018SANRAI INTERNATIONAL LLC
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical p
Terminated
CAFK091272
Mar 13, 2017Valeant Pharmacueticals International
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a p
Terminated
CAFK871427
Feb 7, 2017Thayer Medical Corporation
Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non
Terminated
CAFK111570
Jun 27, 2016Nephron Pharmaceuticals Corp.
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for
Terminated
CAFK120051
Jun 27, 2016Nephron Pharmaceuticals Corp.
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as
Terminated
CAFK120051
Feb 10, 2016Salter Labs
T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
Terminated
CAFK884947
Feb 10, 2016Pharmacaribe llc
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in con
Terminated
CAFK130091
Jan 21, 2016Valeant Pharmacueticals International
Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) a
Terminated
CAFK870051
K871427
Dec 4, 2015Valeant Pharmaceuticals North America LLC
Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to gene
Terminated
CAFK870051
K871427
Sep 17, 2015Salter Labs
NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or
Terminated
CAFK961476
K962879
Jun 6, 2015Compass Health Brands
Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
Terminated
CAFK031413
Dec 12, 2014Teleflex Medical
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebuliz
Terminated
CAFNone listed
Oct 23, 2014Aerogen Ltd.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent
Terminated
CAFK021175
Oct 23, 2014Aerogen Ltd.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent
Terminated
CAFK021175
Oct 23, 2014Aerogen Ltd.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent
Terminated
CAFK021175
Oct 23, 2014Aerogen Ltd.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent
Terminated
CAFK021175
Jul 2, 2012Thayer Medical Corporation
AirLife MiniSpacer MDI Dispenser Adapter. Dual-Spray MiniSpacer Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer is a Metered Dose Inhaler (MDI) D
Terminated
CAFK955805
Aug 12, 2011Carefusion 211 Inc
AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is
Terminated
CAFK780456
Dec 28, 2007Teleflex Creek Dr
HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.
Terminated
CAFK772348
Jan 5, 2005Omron Healthcare, Inc.
Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061
Terminated
CAFK923024
Nov 5, 2004Medical Industries America Inc
Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the fo
Terminated
CAFK032849

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