BEUDAMED
    528 results · 16ms · Sources: EU EUDAMED, US FDA

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    ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software

    FDA Recall
    Terminated ·Viewray, Inc.·Product code IYE·November 18, 2019

    Centricity Enterprise Web

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LLZ·April 28, 2022

    Centricity Universal Viewer Zero Footprint Client

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LLZ·April 28, 2022

    Centricity Radiology RA600

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LLZ·April 28, 2022

    Centricity Cardiology CA1000

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LLZ·April 28, 2022

    Centricity PACS RA1000

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LLZ·April 28, 2022

    Fisher Wallace Stimulator Models FW-100 and FW-200

    FDA Recall
    Open, Classified ·Fisher Wallace Laboratories Inc.·Product code QJQ·April 6, 2023

    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.

    FDA Recall
    Terminated ·Heidelberg Engineering GmbH Tiergartenstr. 15 Heidelberg Germany·Product code OBO·July 3, 2019

    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDB·June 24, 2015

    Ventana HE 600 System, automated slide preparer, for use in laboratories.

    FDA Recall
    Open, Classified ·Ventana Medical Systems Inc·Product code KPA·June 1, 2022

    BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code KPA·February 25, 2021

    Plicator EPS Plication System Catalog Number: 160-01128R

    FDA Recall
    Terminated ·NDO Surgical, Inc.·Product code KOG·January 26, 2007

    Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000

    FDA Recall
    Open, Classified ·Welch Allyn Inc·Product code FLL·July 20, 2021

    Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code MSW·October 18, 2010

    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc. Medina, NY 14103 ** Serial Number: XXXXXX. To be used in a healthcare facility in an IV pole mounted configuration or carried by the user in an ambulatory manner.

    FDA Recall
    Terminated ·Sigma International General Medical Apparatus, Llc·Product code FRN·September 15, 2010

    ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each.

    FDA Recall
    Terminated ·Ortho Organizers Inc·Product code DZD·November 1, 2010

    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·June 14, 2021

    A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNS·June 14, 2021

    A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNS·June 14, 2021

    Mito Red Light, Super Mobile

    FDA Recall
    Open, Classified ·MITO RED LIGHT INC·Product code ILY·February 12, 2025