BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    BTL 799-2L

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....

    Pre-Finisher

    FDA UDI
    TP ORTHODONTICS INC·00192029042205·4 Bicuspid Extraction

    INSUFLOW

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

    CVUE ADVANCED DEFINITIVE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code FJI·June 21, 2013

    EGIA 45 ARTICULATING MED/THICK SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GAG·July 29, 2011

    AVAN REINF RING SS 48/58MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024