BEUDAMED
    385 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·August 30, 2017

    Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·November 5, 2014

    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·August 30, 2017

    LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·June 11, 2014

    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 5, 2023

    Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·June 11, 2014

    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·June 11, 2014

    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

    FDA Enforcement
    Class II ·Terminated·InfuTronix LLC·July 31, 2019

    SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 3, 2015

    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·July 15, 2020

    ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

    FDA Enforcement
    Class II ·Terminated·Baylis Medical Corp *·April 22, 2015

    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems Inc.·February 14, 2018

    etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

    FDA Enforcement
    Class II ·Ongoing·Touch US Llc·August 3, 2022

    Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 20, 2022

    ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.

    FDA Enforcement
    Class II ·Terminated·Baylis Medical Corp *·December 9, 2015

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Enforcement
    Class II ·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·February 9, 2022

    Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor

    FDA Enforcement
    Class II ·Ongoing·Verathon, Inc.·June 12, 2024

    VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

    FDA Enforcement
    Class II ·Terminated·bioMerieux, Inc.·February 19, 2020

    OxyMask O2 Adult REF OM-1125-14

    FDA Enforcement
    Class II ·Ongoing·Southmedic, Inc.·August 4, 2021