BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    Key Scientific Products Incorporated·00850041798028·PEP REAGENT

    N/A

    FDA UDI
    Key Scientific Products Incorporated·00850041798042·Pep ReagentT

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 16, 2023

    STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VAXCEL PORT, MODELS 45-336 AND 45-338

    FDA 510(k)
    FDA Class 2 ·General Hospital

    2.4MM VA LOCKING SCREW STARDRIVE 20MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 29, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 9, 2011

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·July 25, 2008

    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

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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