BEUDAMED
    20 results · 28ms · Sources: EU EUDAMED, US FDA

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    NEXCOMP AND META ETCHANT

    FDA 510(k)
    FDA Class 2 ·Dental

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014605692·MAQUET ALPHAMAXX 3.25" DELUXE GEL

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481123313·LOCATOR F-Tx Abutment For 5.0mm Camlog Connecti...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481113390·LOCATOR R-Tx Abutment for 5.0mm Camlog Connecti...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450292655·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450286302·

    WEISS RETINAL CANNULA

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HARDYDISK, CEFOXITIN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019

    ABG MICRO 1ML 25 GAUGE 5/8" SL

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code CBT·May 25, 2016

    ABG MICRO 1ML 25 GAUGE 5/8" SL

    FDA Adverse Event
    Injury ·CAREFUSION, INC·Product code CBT·April 29, 2016

    ABG MICRO 1ML 25 GAUGE 5/8" SL

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code CBT·May 25, 2016

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 26, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 6, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

    e-fix E19 power drive. The product is a wheelchair component/accessory.

    FDA Recall
    Terminated ·Frank Mobility Systems, Inc.·Product code ITI·August 1, 2004

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014