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

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    ACUSON Sequoia Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    n/a

    FDA UDI
    Ortho Development Corporation·00822409078882·Head Extension +0 mm

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180135611·5MM DIA., 45CM, ELMED BARIATRIC LAPAROSCOPE, 0 ...

    Pomee

    FDA UDI
    POMEE CORPORATION·G15772215000·Iris straight

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00817470002706·CAPS-LOCK ULTRA 8.2MM X 55MM

    Ambler Surgical

    FDA UDI
    AMBLER SURGICAL CORP.·00190660194918·Corneal trephine blade, short, 8.0mm length, 15...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702780451·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702412734·Elvarex 3/Thigh High/Closed Toe, E-Version, Kne...

    Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VACUUM ASSISTED CLOSURE

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

    OXF ANAT BRG LT SM SIZE 3 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·January 6, 2017

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·June 11, 2018

    Truliant

    FDA UDI
    Exactech, Inc.·10885862584083·

    STERILETRAC SYSTEM X-DRIVE THINFLAP 2 HOLE STRAIGHT PLATE

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code JEY·February 10, 2022

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LGD·November 5, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 24, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP·Product code MVK·July 2, 2013

    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