BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    4D SONO-SCAN 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRESTLE LUXE

    FDA UDI
    ALPHATEC SPINE, INC.·00190376215389·TRESTLE LUXE II, ACP, 5-LEVEL, 95

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 31, 2014

    ECLERIS MICROSTAR COLPOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DJ ORTHOPEDICS INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 16, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015