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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SurgiCount+ System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    DEPUY MITEK, LLC·10886705011087·LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894182260·

    INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 11, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    SIGMA CRVD XLK INS 4 8MM

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·November 13, 2008

    MINDRAY NORTH AMERICA

    FDA Adverse Event
    Injury ·MINDRAY NORTH AMERICA·Product code BSZ·August 25, 2011

    EGIA ULTRA UNIVERSAL STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·July 8, 2013

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 26, 2024

    TRULIANT KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 3, 2024

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 26, 2019

    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