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

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    SLICK SET W/SURELOC EXTERNAL CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK

    Ovation® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K310151111·OVATION® C Base Rx 018 U5-5 CS BC6/29/2018 HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

    Ovation® C EURO

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K310151801·OVATION® C EURO 018 U5-5 CS HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5

    Ovation® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K310151101·OVATION® C Base Rx 018 U5-5 CS HK

    SCREWDRIVER 2.5 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 4, 2011

    MC3 Jugular Dual Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 25, 2014

    PRECISION XTRA /OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·October 12, 2007

    PROTECTA XT VR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

    Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 3, 2011

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024