BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    BRIGADE STANDALONE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551054246·FARRIOR Ear Speculum, size 5

    Facebow

    FDA UDI
    ORMCO CORPORATION·00889989029390·Facebow UNILATERAL .045 DIA

    DANmed

    FDA UDI
    DANNORITZER Medizintechnik GmbH & Co. KG·04251351117053·LAP-Insert only, Ø5mm, l=450mm Atraum...

    DANmed

    FDA UDI
    DANNORITZER Medizintechnik GmbH & Co. KG·04251351114809·LAP-Instrument, Ø5mm, l=450mm, detach. Atraum...

    DANmed

    FDA UDI
    DANNORITZER Medizintechnik GmbH & Co. KG·04251351112201·LAP-Instrument, Ø5mm, l=450mm, detach. Atraum...

    DANmed

    FDA UDI
    DANNORITZER Medizintechnik GmbH & Co. KG·04251351110344·LAP-Instrument, Ø5mm, l=450mm, detach. Atraum...

    DANmed

    FDA UDI
    DANNORITZER Medizintechnik GmbH & Co. KG·04251351104435·LAP-Instrument, Ø5mm, l=450mm, detach. Atraum...

    DANmed

    FDA UDI
    DANNORITZER Medizintechnik GmbH & Co. KG·04251351102257·LAP-Instrument, Ø5mm, l=450mm, flushp. Atraum...

    DANmed

    FDA UDI
    DANNORITZER Medizintechnik GmbH & Co. KG·04251351108471·LAP-Instrument, Ø5mm, l=450mm, flushp. Atraum...

    MICRORUPTER V

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIOHARNESS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970577·

    NONE

    FDA Adverse Event
    Injury ·Product code GCY·November 21, 2008

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 21, 2013

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·September 26, 2014

    BAIR HUGGER / 3M

    FDA Adverse Event
    Injury ·3M·Product code DWJ·November 23, 2016

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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

    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