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

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    ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    BACTERIAL FILTER

    FDA UDI
    BIODEX MEDICAL SYSTEMS, INC.·00718175005200·FILTER, BACTERIA / VIRAL, DISPOSABLE (LATEX FREE)

    Freedom Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215027476·

    O2-IN-A-BOX, O2-IN-A-BOX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE

    FDA 510(k)
    FDA Class 2 ·Dental

    PUMP 1886 780G OUS BLE PUMP MG/DL

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 5, 2024

    UNIV 2-HOLE SHL 52MM LNR SZ 23

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MEH·February 14, 2018

    BIOLOX DELTA CERAMIC FEMORAL HEAD 28/-3MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·October 19, 2017

    ALIGN S URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·May 16, 2013

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Other ·MOOG MEDICAL DEVICES GROUP·Product code LZH·June 10, 2011

    JAGWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code EZB·August 22, 2008

    EPOLY 28MM RLC LNR MROM SZ23

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 14, 2018

    TPRLC 133 MP TYPE1 PPS SO 10.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 14, 2018

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 21, 2025

    INTELLAMAP ORION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 2, 2024

    EPOLY 28MM RLC LNR MROM SZ23

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 6, 2017

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 7, 2023

    K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016