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

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    INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HHM

    FDA UDI
    Oticon A/S·05707131269089·H110, DESIGNRITE 10 WL TC HHM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016605·MFx 125 Degree Contoured Reconstruction Plate, ...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197052337·Titan Micro Halstead Hemostatic Forceps curved...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064842·2.4 System 5 x 16 Hole Reconstruction Right Pla...

    VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 9, 2022

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 20, 2020

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    MITEK LUPINE STABILIZATION DRILL BIT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code GFG·May 31, 2013

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE PTE. LTD·Product code FRN·August 29, 2008

    AEM SUCTION IRRIGATION ELECTRODE, SPATULA

    FDA Adverse Event
    Malfunction ·ENCISION·Product code GEI·June 18, 2011

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·August 6, 2020

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025