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

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    U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030917·Vaginal Delivery Pack

    NOVO Health Services, LLC

    FDA UDI
    SRI Healthcare, LLC·00810019801723·Vaginal Delivery Pack

    M-Flex®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020074·Blue Silicone Tungsten Maloney Esophageal Dilat...

    MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES MATRIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·May 20, 2013

    VANGUARD SSK PS TIBIAL BEARING 14X79/83

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·September 26, 2014

    014 HT WINN GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·June 10, 2011

    THERAKOS UVAR XTS PHOTOPHERESIS SYS

    FDA Adverse Event
    Malfunction ·THERAKOS, INC.·Product code LNR·January 6, 2014

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·December 26, 2012

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·November 5, 2012

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017