BEUDAMED
    28 results · 24ms · Sources: EU EUDAMED, US FDA

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    EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VARELISA SM ANTIBODIES, MODEL 18296

    FDA 510(k)
    FDA Class 2 ·Immunology

    ONSET ACCESS CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXOR RTPS GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·February 27, 2020

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·June 3, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·September 26, 2014

    AFFINITY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code HDD·June 21, 2011

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    PKG, 5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080757 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

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 29, 2020

    FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 3, 2020

    THAL-QUICK CHEST TUBE SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GBX·January 7, 2020

    FLEXOR ANSEL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 3, 2020

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 10, 2022

    FLEXOR ANSEL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·October 22, 2019

    FLEXOR RAABE GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 11, 2019

    FLEXOR ANSEL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·October 22, 2019

    FLEXOR RAABE GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 27, 2019

    FLEXOR ANSEL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 18, 2019