BEUDAMED
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    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·March 26, 2014

    VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.

    FDA Recall
    Terminated ·Ethicon, Inc US·Product code HIH·December 16, 2004

    PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PRONOVA SUTURE BLUE 122CM M1.5, D10189

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

    FDA Recall
    Terminated ·Fresenius Kabi USA, LLC·Product code PHC·September 8, 2022

    PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·November 26, 2014

    PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

    FDA Enforcement
    Class I ·Terminated·Fresenius Kabi USA, LLC·October 12, 2022

    PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018