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

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    NEOCONTROL PELVIC FLOOR THERAPY SYSTEM

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

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105633·PowerChem Neoprene Exam Gloves, Medium

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964015944·Endo Carry-On Procedure Kit

    3i Certain®-compatible

    FDA UDI
    Preat Corporation·00842092181959·3i Certain®-compatible 6.0mm Digital Analog Kit...

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161393256·GRADIA® gum Modifier (GM34), 2.4 mL

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470019031·GRADIA® gum Modifier (GM34), 2.4 mL

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795034939·MTP Spin Guard™ Male Reamer, 19mm

    Acid Etching

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746007804·ETCHING SOLUTION SEMI GEL 9 GMS

    CARDIOSAVE HYBRID, TYPE I PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·April 22, 2025

    Z-NET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CastleLoc Pectus Bar System Instrument Set

    FDA UDI
    L&K BIOMED CO. ,LTD.·08809986460318·EZ Crane System 3

    XGAUZE Trauma Pad

    FDA UDI
    Revmedx, Inc.·00851587006073·XGAUZE Trauma Pad Sterile Wound Dressing

    DRIVER SHAFT, T-15, MEDIUM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code LXH·October 15, 2019

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 13, 2013

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·August 12, 2014

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC PUMP CE ENGLISH

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE PTE LTD·Product code FRN·February 21, 2008

    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·August 28, 2024

    Wound Management Tray Aten cion med. EN El Hogar, catalog# 900-1903

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCY·December 8, 2011

    Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014