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

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    BP5S Wireless Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111107948·ROCH-CARMALT FCP STR 6 1/4"

    APEX KNEE SYSTEM, APEX ALL POLY TIBIA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLIDER PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIZACT

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·June 18, 2019

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 14, 2013

    HCG COMBO DEVICE SP BRAND RAPID TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code JHI·July 14, 2014

    4.5MM LCP CURVED CONDYLAR PLATE/14 HOLES/314MM-RIGHT

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code KTT·July 8, 2011

    NI

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 23, 2018

    BIZACT

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·April 30, 2024

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    BIZACT

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·April 30, 2024

    BIZACT

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·October 19, 2020

    BIZACT

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·October 19, 2020

    BIZACT

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·October 19, 2020

    BIZACT

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·October 21, 2020

    BIZACT

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·April 30, 2024

    BIZACT

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·May 2, 2024

    BIZACT

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·May 24, 2024

    BIZACT

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·April 25, 2024