BEUDAMED
    33 results · 27ms · Sources: EU EUDAMED, US FDA

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    GENERAL SEMEN ANALYSIS (GSA) KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197152129·Vise Micro Suture Tying Forceps curved...

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·July 21, 2024

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·July 21, 2024

    READI-STRAND; MODEL PSSTRAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    AART PECTORALIS IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 28, 2025

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·April 3, 2025

    1 X 8 COMPACT TEST STIM LEAD

    FDA Adverse Event
    Injury ·NEURO - VILLALBA·Product code LGW·March 27, 2013

    CAPSURE Z

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 18, 2011

    CLEARSTAR PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·April 3, 2008

    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Constellation Procedure Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Centurion FMS Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Alcon Custom Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Legion FMS Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Phaco Standalone Tips

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Infinity FMS Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code LRO·May 16, 2014

    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

    FDA Recall
    Terminated ·Alcon Research LLC Aspex Facility·Product code HQL·April 17, 2020