BEUDAMED
    15 results · 31ms · Sources: EU EUDAMED, US FDA

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    WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER

    FDA 510(k)
    FDA Class 2 ·Radiology

    LPC-PLUS ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2024

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 29, 2013

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 13, 2011

    SAGB QUICK CLOSE

    FDA Adverse Event
    Injury ·OBTECH MEDICAL SARL·Product code LTI·July 29, 2008

    ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0°, RETRO

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·November 21, 2018

    ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWT·November 21, 2018

    ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-0

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWS·November 21, 2018

    ANATOMICAL SHOULDER FRACTURE, HUMERAL STEM, 7-130

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWS·November 21, 2018

    BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·June 17, 2015

    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