BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Xelis Dental 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    EarQ

    FDA UDI
    Oticon A/S·05707131342331·G10, BTE 13 2.4G 85 C090 EARQ

    VAULT ALIF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZIMMER PERSONA KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXGEN PROVISIONAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020

    911 HITACHI

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2008

    RADIOLUCENT-DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·June 27, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 29, 2011

    MIRU 1DAY UPSIDE (MIDAFILCON A)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·January 22, 2025

    VANGUARD MONO FINNED STM TIB 71X14

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·December 9, 2024

    VANGUARD ROCC TIB BRG UHMWPE 60X10MM

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025

    PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018