BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    IRIS INTELLIGENT RETINAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VOCARE MYHEALTH TABLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES PR·Product code JXG·January 27, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 28, 2011

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·November 20, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·December 19, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 8, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 22, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·January 26, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·February 12, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

    PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. 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