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

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    Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113271·STAB KNIFE 15 DEGREE (BX/5)

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102374·BARRAQUER IRIS SPATULA 0.25MM

    ASCOT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS

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

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523102334·R CR MAXTM HXL Ultracongruent Tibial Insert Sz ...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145232·R CR UHMWPE Ultracongruent Tibial Insert Sz B 10mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101566·R E-MAXTM Vitamin E Ultracongruent Tibial Inser...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124572·R Ultracongruent Tibial Insert Trial Sz B 10mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523164592·R Ultracongruent Tibial Insert Trial with Anter...

    PEGASUS YEL 24GAX0.75IN QSYTE-CAPY NOPVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·January 14, 2020

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEATHCARE CORPORATION·Product code KDI·November 6, 2014

    QUANTA SYSTEMS S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·November 18, 2015

    A200 KNEE SYSTEM

    FDA Adverse Event
    Injury ·RENOVIS SURGICAL TECHNOLOGIES, INC.·Product code JWH·September 16, 2016

    smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    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