24 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025
FDA Recall
Terminated
·Acclarent Inc·Product code LRC·January 20, 2006
Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive, Menlo Park, CA 94025 Product Usage: Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 30, 2012
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 Recall
Terminated
·Acclarent, Inc.·Product code KAM·April 28, 2015
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 11, 2013
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
FDA Recall
Terminated
·Acclarent, Inc.·Product code PGW·March 6, 2019
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 11, 2013
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 11, 2013
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 11, 2013
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 11, 2013
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 11, 2013
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 11, 2013
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
FDA Recall
Terminated
·Acclarent, Inc.·Product code PGW·March 6, 2019
TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
FDA Recall
Terminated
·Acclarent, Inc.·Product code PGW·March 6, 2019
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