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

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    V200 INTELLI-TRAK OPTION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CAPNOPROBE SL, MODEL 2000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 10, 2024

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

    BIOMET CC CRUCIATE TRAY 79MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·September 23, 2014

    COLLEAGUE PRE P1.7

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

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    Video Duodenoscope

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024