BEUDAMED
    29 results · 22ms · Sources: EU EUDAMED, US FDA

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    Epic Extremity Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517566546·CoRoent Ant TLIF PEEK, 15x13x34mm 0°

    TROUTMAN-BARRAQUER NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896074590·TROUTMAN-BARRAQUER NEEDLE HOLDER WITHOUT LOCK S...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100301·INFANT WIRE SPECULUM 3MM/5MM BLADES

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111054990·SKLHN GOLDMAN-FOX SCISS CVD 5"

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM

    SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 17, 2022

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 8, 2013

    BAUSCH & LOMB STELLARIS PHACOEMULSIFICATION SY

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQC·June 30, 2011

    UNK OUTBACK

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DQY·September 5, 2008

    FREESTYLE PRECISION NEO H

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

    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

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    DYB INTRODUCER, CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·November 12, 2025

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    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

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 15, 2020