BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    CastleLoc-S Posterior Cervical Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LoFric® Hydro-Kit™

    FDA UDI
    Wellspect AB·07392532142703·Single Use Urinary Catheter LoFric Hydro-Kit Ne...

    MILAGRO

    FDA UDI
    DEPUY MITEK, LLC·10886705010837·MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLG...

    NA

    FDA UDI
    Zimmer, Inc.·00889024049482·

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102237·SLOANE LASEK MICRO HOE

    NA

    FDA UDI
    Zimmer, Inc.·00889024049499·

    Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAREMATIX WELLNESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMP,TSV,4.1MM,DUAL SEL,HA

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·December 1, 2025

    LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 26, 2022

    ENDOSCOPIC CUTTER AND STAPLE CART.

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGICAL·Product code KOG·October 31, 2014

    MODULAR HEAD COMPONENT 28MM HEAD DIAMETER MINUS 3MM NECK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 1, 2011

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·July 12, 2013

    10 X 30MM MILAGRO INTERFERENCE SCREW

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·January 25, 2019

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025