57 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vital Signs™
FDA UDI
Vyaire GmbH·10190752136434·Patient Circuit, Expandable, Pediatric, Disposa...
Vital Signs™
FDA UDI
Vyaire GmbH·10190752111349·Anesthesia Gas Sampling Line, Disposable, 2.5 m...
VYAIRE
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code CAH·October 25, 2023
MICROBLENDER
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL INC.·Product code BZR·January 27, 2022
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
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 Recall
Open, Classified
·Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany·Product code BZC·April 8, 2024
VYNTUS ONE PC
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BZC·September 18, 2024
VYNTUS SPIRO LAPTOP
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BTY·September 18, 2024
VMAX VYNTUS SPIRO LAPTOP
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BTY·August 14, 2024
VYNTUS SPIRO TP SPIROMETER
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BTY·July 5, 2024
PRODUCT VYNTUS CPX TABLE
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BZC·January 26, 2023
VYNTUS SPIRO LAPTOP
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BTY·September 17, 2024
PRODUCT VYNTUS BODY
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code JEH·September 27, 2023
VYNTUS
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BZC·August 30, 2023
PRODUCT VYNTUS BODY
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code JEH·September 27, 2023
JAEGER
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BZC·July 25, 2023
PRODUCT VYNTUS BODY
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code JEH·September 27, 2023
VYNTUS
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BZC·December 16, 2020
VYAIRE
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code BZC·May 20, 2024
MICROGARD II BACT/VIRAL FILTER
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code CAH·June 19, 2024