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

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    SofWave System

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

    Walgreens

    FDA UDI
    WALGREEN CO.·00311917153445·Walgreens Finger Sleeve w/Gel Insert 2s

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158210288·FORCEPS DEBAKEY ATRAUMATIC TISSUE 2MM TIP STRAI...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00198506060069·DEBAKEY FORCEPS, 8", STRAIGHT 2MM

    EVERSTICK POST

    FDA 510(k)
    FDA Class 1 ·Dental

    EXPANDABLE LUMBAR INTERBODY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLUSET 150 X 60 BURETTE SET, LATEX FREE

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPK·November 6, 2008

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

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

    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