BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17

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

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037315019·Ø36 Eccentric Glenosphere with +0mm lateralized...

    MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE

    FDA 510(k)
    FDA Class 2 ·Dental

    SYRINGE 0.5ML 31G TW 6MM BLS 400 SG

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code MEG·September 17, 2019

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·April 17, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·April 19, 2011

    AXSYM RUBELLA IGG ANTIBODY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LFX·June 19, 2008

    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·October 25, 2017

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022