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

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    PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01

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

    MI Product Line

    FDA UDI
    Medical Illumination International Inc.·00816835020218·MI-750 Minor Surgical Light, Dual Ceiling

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X0614250·6mm H x 14mm W x 25mm L x 0 degrees XLIF

    MI Product Line

    FDA UDI
    Medical Illumination International Inc.·00816835020775·MI-750 Minor Surgical Light, Dual Ceiling

    VISION EX5

    FDA UDI
    Avante·00815871022279·DRE Vision EX5, DUAL CEILING

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L061425120·6mm H x 14mm W x 25mm L XLIF Trial 12 degree Lo...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X061425120·6mm H x 14mm W x 25mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X06142580·6mm H x 14mm W x 25mm L x 8 degrees XLIF

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"

    VISION EX5

    FDA UDI
    Avante·00815871022316·DRE Vision EX5, DUAL CEILING

    GENTLEWAVES LED PHOTOMODULATION DEVICE

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

    CARMEN

    FDA 510(k)
    FDA Class 2 ·Dental

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·November 4, 2015

    XLD 110V L.A. REF

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 10, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS·Product code LKK·June 17, 2008

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 18, 2011

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·November 17, 2017

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LIT·May 23, 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

    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