BEUDAMED
    22 results · 26ms · Sources: EU EUDAMED, US FDA

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    Actively Trying Personal Lubricant Unfragrance

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

    Richard-Allan® Needle 1/2 Circle Reverse Cutting

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00840113215300·Intent to be used with suture material for tiss...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252096016·LeFort I Plate, 5mm advancement, right

    Plateau-C Ti

    FDA UDI
    Life Spine, Inc.·00190837067229·Custom Small Anatomical Spacer, 7degree, 5mm

    AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CLEARFIL PHOTO CORE

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA Adverse Event
    Malfunction ·ASCENT HEALTHCARE SOLUTIONS·Product code NBH·October 22, 2008

    EXPEDIUM ULTRA ROD 5.5X700MM

    FDA Adverse Event
    Injury ·DEPUY SPINE INC.·Product code KWP·August 11, 2011

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 9, 2013

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code DYE·July 3, 2024

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code DYE·May 20, 2024

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code DYE·June 24, 2024

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code DYE·May 17, 2024

    INSPIRIS RESILIA AORTIC VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·June 5, 2024

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code DYE·May 15, 2024

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 5, 2024

    MITRIS RESLIA MITRAL VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code LWR·May 24, 2024

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code LWR·December 9, 2024

    HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·November 6, 2013

    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS

    FDA Recall
    Terminated ·Kaneka America Corp·Product code MMY·February 17, 2022