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

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    Hive™ Standalone Cervical System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Duet Long-Term Hemodialysis Catheter System

    FDA UDI
    Bard Access Systems, Inc.·00801741011955·DUET HEMODIALYSIS CATH, 10 FR. SL 19A/22V

    Suede Thumb support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357231904·

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114148·SIMCOE I/A SYSTEM 23GA (PK/3)

    E.CAM COMPUTER / E.SOFT WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Surgical Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GII PLASTIC REAMTHRU FEM TRL SZ 3 RT

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code JWH·December 21, 2018

    GII PLASTIC REAMTHRU FEM TRL SZ 6 RT

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code JWH·December 21, 2018

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·October 27, 2014

    COULTER GENS HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKL·August 12, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 12, 2013

    PT HYBRID GLEN POST REGENEREX

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·August 29, 2022

    VERSA-DIAL 46X24X47 HUM HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·August 29, 2022

    SM HYBRID GLENOID BASE 4MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·August 29, 2022

    XP-XP Tibial Tray - Interlok 75 mm Item # 195757

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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