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

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    LIFE SCOPE P, MODEL BSM-4100 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756337229·Pediatric Anesthesia Circuit

    UMECO OPTIMA MULTILINE LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CANDELA SPTL-1B PULSED DYE LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·July 9, 2018

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·March 8, 2013

    PRODISC-C IMPLANT MEDIUM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·February 22, 2011

    STARCLOSE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MGB·February 15, 2008

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018