BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    NR Recorder

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523104086·T³ Acetabular Hemispherical Shell, Cluster Hole...

    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

    MPACT ACETABULAR SHELL Ø56 MULTI-HOLE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·June 16, 2017

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·June 16, 2011

    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

    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 Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022