BEUDAMED
    23 results · 26ms · Sources: EU EUDAMED, US FDA

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    VIPER SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108130·CASTROVIEJO NEEDLE HOLDER CURVED W/ LOCK

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0115200·Needle, Bevel Stylet, Stainless Steel, Disposable

    ALPHA OMEGA DUAL COOLER-HEATER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE-X

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPREHENSIVE LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019

    M2A-MAGNUM 52-60MM TAPER INSERT-3

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·January 31, 2017

    M2A-MAGNUM MODULAR HEAD SZ 52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·January 31, 2017

    IMPL-HOLDER F/SYNFIX-LR

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code LXH·April 16, 2013

    2-L HUB CONNECT ASSY REP LACEMENT SET

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code NFK·March 16, 2011

    TAPERED TOOL LEGEND, F2/8TA23

    FDA Adverse Event
    Malfunction ·MEDTRONIC POWERED SURGICAL SOLUTION·Product code HBB·June 17, 2008

    ACT ARTIC HD ARCOM XL 28X44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 13, 2021

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·July 13, 2021

    COMP RVS TRAY CO 44MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWS·November 9, 2017

    ARCOM XL 44-36 STD HMRL BRNG

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PAO·November 9, 2017

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 15, 2017

    M2A-MAGNUM MOD HD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·July 15, 2019

    M2A-MAGNUM PF CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 15, 2019

    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