BEUDAMED
    265 results · 18ms · 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

    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

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Recall
    Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510 150 test iQM Part Number:00027415010 300 test iQM Part Number: 00027430010 450 test iQM Part Number: 00027445010 600 test iQM Part number: 00027360010 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011

    LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360 in either direction. The rotating knob is located to allow for a one-handed technique.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GDO·April 12, 2013

    WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GDO·August 24, 2016

    Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.

    FDA Recall
    Terminated ·Product code GDO·October 31, 2001