13 results
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32ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·January 29, 2020
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·January 29, 2020
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·January 29, 2020
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·August 7, 2013
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·August 7, 2013
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·August 7, 2013
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·August 7, 2013
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·August 7, 2013
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·August 7, 2013
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
FDA Enforcement
Class II
·Terminated·Acclarent, Inc.·August 7, 2013
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
FDA Enforcement
Class III
·Terminated·Acclarent, Inc.·June 17, 2015
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
FDA Enforcement
Class II
·Ongoing·Acclarent, Inc.·November 1, 2023
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
FDA Enforcement
Class II
·Ongoing·Acclarent, Inc.·December 29, 2021