BEUDAMED
    24 results · 28ms · Sources: EU EUDAMED, US FDA

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    GENESIS DM MODEL: 6053000A1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bur PM2-95 80K Diam EC Ø4.7 St

    FDA UDI
    Bien-Air Surgery SA·17630055516791·

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04250317300423·

    AIM™FEMORAL NAIL

    FDA UDI
    Biomet Orthopedics, LLC·00887868003431·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112420·Awl Tap, 4.75 mm, Fixed Sleeve

    ALLURE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807101242111·ALLURE® MB Base Rx .022 UL4 -7T 0A 2D HK

    ALLURE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807101242141·ALLURE® MB Base Rx .022 UL4&5 -7T 0A 2D

    MaxFuse VBR, 10 (D) x 12 (W) x 27 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055080·10 (D) x 12 (W) x 27 (H)

    ISOLETTE INFANT INCUBATOR, MODEL C2HS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·February 22, 2019

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 2, 2019

    CG FUTURE BAND

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 15, 2018

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    ADVANIX BILIARY STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·May 24, 2011

    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    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

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021