BEUDAMED
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    Clinical Chemistry Uric Acid; LN 7D76-20

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

    EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·March 28, 2013

    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code NPT·July 9, 2019

    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code NPT·July 9, 2019

    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code NPT·July 9, 2019

    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code NPT·July 9, 2019

    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

    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

    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

    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

    CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DXJ·May 5, 2009

    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

    Plicator EPS Plication System Catalog Number: 160-01128R

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

    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·March 5, 2014

    Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007

    FDA Recall
    Terminated ·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MHX·August 11, 2010

    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDD·May 8, 2012

    IMMULITE /IMMULITE 1000 Vitamin B12

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDD·January 2, 2018