BEUDAMED
    22 results · 12ms · Sources: EU EUDAMED, US FDA

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    ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.

    FDA Enforcement
    Class II ·Terminated·Data Innovations, LLC·September 24, 2014

    CryoValve, Aortic Valve and Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·February 18, 2004

    CryoValve, Pulmonary Valve and Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·February 18, 2004

    Flexiflo Quantum Enteral Pump

    FDA Recall
    Terminated ·Ross Products Division Abbott Laboratories·Product code LZH·August 18, 2004

    Pencil Point Spinal Tray, Lot number 0504243

    FDA Recall
    Terminated ·Spinal Specialties, Inc·Product code LRO·June 18, 2004

    Gertie Marx PainPak, Lot number 0504305, Reorder number 4060

    FDA Recall
    Terminated ·Spinal Specialties, Inc·Product code LRO·June 18, 2004

    Custom Convenience Kit

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DQO·October 15, 2004

    Clinical Chemistry Uric Acid; LN 7D76-20

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code CDO·March 18, 2004

    Safety Paracentesis Procedure Tray

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DQY·October 15, 2004

    CryoValve Pulmonary Valve SG

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·June 17, 2004

    CryoValve Aortic Valve and Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·June 17, 2004

    CryoValve Pulmonary Valve and Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·June 17, 2004

    Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 10 cm, sterile, single use only; Ref 3102.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FGE·June 18, 2004

    Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FGE·June 18, 2004

    AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

    FDA Enforcement
    Class I ·Terminated·Stryker Sustainability Solutions·July 27, 2016

    ATS Open Pivot Mechanical Heart Valve

    FDA Recall
    Terminated ·ATS Medical, Inc.·Product code LWQ·February 18, 2004

    EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40 boxes per case. Firm on label: Schneider/NAMIC, Glens Falls, New York 12801

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code DYB·June 24, 2004

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295, Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett·Product code DQA·October 18, 2004

    Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland, Oxismart, Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett·Product code DQA·October 18, 2004