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Crédits
Manufacturers
Acclarent, Inc.
Adresse du fabricant
Acclarent, Inc., 1525-B O'Brien Dr, Menlo Park CA 94025-1463
Société-mère du fabricant (2017)
Johnson & Johnson
Source
USFDA
7 Events
Rappel de Device Recall Inspira AIR Balloon Dilation system
Rappel de Device Recall Inspira AIR Balloon Dilation system
Rappel de Device Recall Inspira AIR Balloon Dilation system
Rappel de Device Recall Inspira AIR Balloon Dilation system
Rappel de Device Recall Inspira AIR Balloon Dilation system
Rappel de Device Recall Inspira AIR Balloon Dilation system
Rappel de Device Recall Inspira AIR Balloon Dilation system
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7 dispositifs dans la base de données
Device Recall Inspira AIR Balloon Dilation system
Modèle / numéro de série
Product code: BC1640A; All lots manufactured after March 1, 2011
Classification du dispositif
Ear, Nose, and Throat Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description du dispositif
Inspira AIR Balloon Dilation system. || Size 16 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
Device Recall Inspira AIR Balloon Dilation system
Modèle / numéro de série
Product code: BC1440A; All lots manufactured after March 1, 2011
Classification du dispositif
Ear, Nose, and Throat Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description du dispositif
Inspira AIR Balloon Dilation system. || Size 14 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
Device Recall Inspira AIR Balloon Dilation system
Modèle / numéro de série
Product code: BC1240A; All lots manufactured after March 1, 2011
Classification du dispositif
Ear, Nose, and Throat Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description du dispositif
Inspira AIR Balloon Dilation system. || Size 12 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
Device Recall Inspira AIR Balloon Dilation system
Modèle / numéro de série
Product code: BC1040A; All lots manufactured after March 1, 2011
Classification du dispositif
Ear, Nose, and Throat Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description du dispositif
Inspira AIR Balloon Dilation system. || Size 10 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
Device Recall Inspira AIR Balloon Dilation system
Modèle / numéro de série
Product code: BC8524A; All lots manufactured after March 1, 2011
Classification du dispositif
Ear, Nose, and Throat Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description du dispositif
Inspira AIR Balloon Dilation system. || Size 8.5 x 24 mm, Syringe volume 12 cc. || Dilation of airway tree.
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Acclarent, Inc.
Adresse du fabricant
Acclarent, Inc., 1525B Obrien Dr, Menlo Park CA 94025-1463
Société-mère du fabricant (2017)
Johnson & Johnson
Source
USFDA
Acclarent, Inc.
Adresse du fabricant
Acclarent, Inc., 1525b Obrien Dr, Menlo Park CA 94025-1463
Société-mère du fabricant (2017)
Johnson & Johnson
Source
USFDA
Language
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