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

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    GRADIA DIRECT X

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO CARTO EP NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867523357·DILATOR, 7.0 X 190MM

    SpiderFX

    FDA UDI
    Covidien LP·00821684040522·Embolic Protection Device

    SpiderFX™

    FDA UDI
    EV3, INC·00821684068373·EP SPD2-US-070-190 SPIDER FX V04

    AVISTA MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 24, 2021

    UNKNOWN DEPUY FB TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 25, 2011

    TOTAL ASR FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·April 22, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2008

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 25, 2013

    M2A-MAGNUM PF CUP 48ODX42ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 14, 2020

    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