BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LuxaPrint Ortho Flex 385

    FDA UDI
    DMG Digital Enterprises SE·D9821712530·(Meth) acrylate-based light-curing resin for th...

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012887·K-Wires, Single diamond, round end, .062-inch (...

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049507·K-Wires, Single diamond, round end, .062-inch (...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293203·

    RII INFRARED EAR THERMOMETER, MODEL: TH60N

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 14, 2013

    LCS FEM 75MM LG LT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·September 19, 2008

    LIVER ACCESS AND BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·July 15, 2024

    LIVER ACCESS AND BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·June 29, 2020

    LIVER ACCESS AND BIOPSY SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·June 14, 2024

    LIVER ACCESS AND BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·August 19, 2021

    LIVER ACCESS AND BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·May 15, 2023

    LIVER ACCESS AND BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·February 14, 2023

    LIVER ACCESS AND BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 7, 2023

    LIVER ACCESS AND BIOPSY SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·January 27, 2022

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025