BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    GAELTEC MPR SERIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RIWO-ART

    FDA UDI
    Richard Wolf GmbH·04055207022221·TROCAR SLEEVE STRAI. CAP 5.5MM WL 60MM stainle...

    PAQ.210X140X180/QT-HS80/SCH MS-2015

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763038405·

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150584·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 150mm

    CHITO-SEAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DISSECTOR INSERT CEV601-1 350MM DELAITRE [MXI/XOM]

    FDA Adverse Event
    Malfunction ·MEDTRONIC MICROFRANCE·Product code LRC·January 17, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 9, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014

    RT-5100 Refractor, a component of the Epic-5100 System.

    FDA Enforcement
    Class III ·Terminated·Nidek Inc.·December 26, 2018

    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