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

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    PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Comprehensive® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00880304472679·

    BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET

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

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·November 18, 2014

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·May 14, 2015

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·March 19, 2015

    SUMMIT POR TAPER SZ4 HI OFF

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 15, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·September 24, 2014

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·June 3, 2011

    VERSA-DIAL/COMP TI STD TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·April 3, 2018

    PT HYBRID GLEN POST REGENEREX

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 3, 2018

    VERSA-DIAL 46X21X50 HUM HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·April 3, 2018

    SM HYBRID GLENOID BASE 4MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 3, 2018

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·June 5, 2015

    COMP RVS TRAY +5MM CO 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·April 10, 2019

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·April 10, 2019

    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025