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

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    AAP CANNULATED SCREW AND DARCO HEADED SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110917·LOCATOR R-Tx Abutment for 3.8mm Camlog Connecti...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114533·LOCATOR F-Tx Abutment for 3.8mm CAMLOG Connecti...

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604503·ENDREST TABLE PAD DELUXE WITH VELCRO KIT

    RX VIATRAC 14 PERIPHERAL DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024377516·ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH...

    NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·July 25, 2024

    NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·July 25, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 4, 2025

    *

    FDA Adverse Event
    Malfunction ·COOK, INC·Product code DQR·March 27, 2013

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·May 6, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·July 17, 2008

    BD MICROLANCE HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 30, 2023

    BENCHMARK ULTRA

    FDA Adverse Event
    Malfunction ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 26, 2024

    BD¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·August 31, 2018

    NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·July 25, 2024

    BD¿ BULK, NON-STERILE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 16, 2019

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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