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

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    ProLift Micro Expandable Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EpiStrap Tennis Elbow

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357234301·

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730008374·Votion .022 MC LR4 HK G/O -12T 2A 0O (10PK)

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707114060·Votion .022 MC LR4 HK G/O -12T 2A 0O (10PK)

    Pinnacle®

    FDA UDI
    Ortho Organizers, Inc.·00190707112158·Pinnacle .022 MC LR4 HK G/O -12T 2A 0O (10PK)

    Pinnacle

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730010209·Pinnacle .022 MC LR4 HK G/O -12T 2A 0O (10PK)

    UF BRACHYTHERAPY STAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROSLIDER TEARAWAY INTRODUCER SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRANSSEPTAL NEEDLE, BRK SERIES

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL, COSTA RICA LTDA·Product code DRC·July 31, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 4, 2014

    MAXISKY 600

    FDA Adverse Event
    Malfunction ·BHM MEDICAL, INC.·Product code FSA·June 23, 2011

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

    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