57 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.
FDA Enforcement
Class I
·Ongoing·Vyaire Medical, Inc.·May 15, 2024
The Tri-Flo Subglottic Suction System
FDA Enforcement
Class I
·Terminated·Vyaire Medical·August 29, 2018
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·May 21, 2025
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator.
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·May 21, 2025
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Enforcement
Class I
·Terminated·Vyaire Medical·May 16, 2018
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Enforcement
Class I
·Terminated·Vyaire Medical·May 16, 2018
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Enforcement
Class I
·Terminated·Vyaire Medical·May 16, 2018
AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Enforcement
Class I
·Terminated·Vyaire Medical·May 16, 2018
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Enforcement
Class I
·Terminated·Vyaire Medical·May 16, 2018
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Enforcement
Class I
·Terminated·Vyaire Medical·May 16, 2018
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Enforcement
Class I
·Terminated·Vyaire Medical·May 16, 2018