BEUDAMED
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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

    TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

    FDA Recall
    Open, Classified ·Acclarent, Inc.·Product code PGW·September 21, 2023

    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

    FDA Recall
    Open, Classified ·Acclarent, Inc.·Product code PGW·November 12, 2021

    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