BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    APEX KNEE SYSTEM, APEX ALL POLY TIBIA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Depth gauge

    FDA UDI
    Jeil Medical Corporation·08809282815539·

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015456·microSelectron Transfer Tube for 5F Flexibles (10)

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450159361·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390865869·

    MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG

    FDA 510(k)
    FDA Unclassified ·Unknown

    GLIDER PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103720·Hemispherical Shell, No Hole, 62mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166343·Initia T3 Acetabular Hemispherical Shell, No Ho...

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024130081·

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024130104·

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024130111·

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024130098·

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 4, 2022

    ERGOLIFT

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·April 19, 2013

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 23, 2014

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 18, 2011

    ARTEFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·January 15, 2016

    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