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

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    Altus Spine Titanium Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003555·MCK FEMORAL TRIAL (SIZE 2 RM/LL)

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707018742·CALIBRA 1ST MOLAR BANDS n.LL 12

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776177102·GRAVES VAG SPEC SMALL OPENSIDED RIGHT

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 28, 2019

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·June 29, 2018

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107446·TRIAL 90-SRK-170512 POLY UCCS 5X12MM

    NOBELPROCERA IPS E.MAX CROWN

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NIKO-FIX

    FDA Adverse Event
    Injury ·UNOMEDICAL LTD.·Product code KMK·December 18, 2014

    CVS

    FDA Adverse Event
    Injury ·ASO LLC·Product code KGX·October 9, 2014

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Other ·MERZ AESTHETICS, INC.·Product code LMH·June 5, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 21, 2011

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·March 7, 2024

    SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·October 29, 2024

    SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·October 29, 2024

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 4, 2025

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022