BEUDAMED
    12 results · 31ms · Sources: EU EUDAMED, US FDA

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    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·October 18, 2017

    Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

    FDA Recall
    Terminated ·Bioseal Corporation·Product code BZA·August 15, 2019

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·November 15, 2017

    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

    FDA Enforcement
    Class II ·Terminated·Bioseal Corporation·August 19, 2020

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices