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

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    Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    CryoValve, Pulmonary Valve & Conduit SG

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·August 18, 2003

    Misys Laboratory, version 5.3 with Reference Laboratory Interface

    FDA Recall
    Terminated ·Sunquest Information Systems·Product code JQP·October 18, 2002

    Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HWE·May 31, 2016

    SKBM Microkeratome cutting tool

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code HNO·November 18, 2002

    Portex 1st Response Adult Manual Resuscitators Ref: 8500P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002

    Portex 1st Response Adult Manual Resuscitators Ref: 8503P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002

    Portex 1st Response Adult Manual Resuscitators Ref: 8506P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002

    Misys Laboratory versions 5.23 and 5.3 with Callback

    FDA Recall
    Terminated ·Sunquest Information Systems·Product code JQP·October 18, 2002

    AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JJE·December 18, 2002

    Olympus Sterile Optical Laser Fiber, single use and reusable

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

    Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012