BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER

    FDA 510(k)
    FDA Class 2 ·Immunology

    MSI Precision Specialty Instruments

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

    Clement Clarke International

    FDA UDI
    CLEMENT CLARKE INTERNATIONAL LIMITED·05023323029454·ONE WAY VALVE: EXP (5X20)

    ArgenZ HT+ 98x20 B4

    FDA UDI
    ARGEN CORPORATION, THE·D818122062·Dental porcelain/ceramic restoration kit

    16PW - Class A Burn 21 - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620626·16PW - Class A Burn 21 - Poly White

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973134·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970461·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970454·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973615·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973608·

    IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·May 21, 2013

    JAGWIRE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·September 26, 2014

    UNKNOWN DEPUY INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 3, 2011

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024

    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

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    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