BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    ACUFEX ROTATOR CUFF FIXATION BUTTON

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SILICONE COATED GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GYNECARE TVT OBTURATOR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code OTN·February 22, 2023

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·December 20, 2010

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 17, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 27, 2012

    GYNECARE TVT OBTURATOR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code OTN·January 6, 2023

    GYNECARE TVT OBTURATOR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code OTN·April 5, 2023

    COMP LK SCR 3.5HEX 4.75X30 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 29, 2022

    COMP LK SCR 3.5HEX 4.75X25 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 29, 2022

    COMP LK SCR 3.5HEX 4.75X15 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 29, 2022

    PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014