BEUDAMED
    209 results · 10ms · Sources: EU EUDAMED, US FDA

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    Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·April 11, 2018

    McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.

    FDA Enforcement
    Class II ·Terminated·McKesson Israel Ltd.·September 12, 2018

    Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

    FDA Recall
    Terminated ·Signal Medical Corporation·Product code GFJ·February 20, 2017

    VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CFJ·June 12, 2013

    Advia Chemistry Assay: Lactate

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·March 17, 2016

    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code GFJ·November 11, 2019

    Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CFJ·May 7, 2015

    Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFJ·April 3, 2017

    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

    FDA Recall
    Terminated ·Medtest Holdings, Inc.·Product code CFJ·July 8, 2011

    Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CFJ·August 11, 2020

    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CFJ·August 11, 2020

    Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista System.Cat. No. K2054, Mat. No. 10464323

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·October 11, 2018

    IV KIT - SORBAVIEW IVS3475

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code LRS·April 24, 2019

    CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019

    INFUSA PORT KIT DYNDC1840F

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code LRS·April 24, 2019

    PORT AND IO ACCESS DRESSING KIT DT15780A

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OXQ·April 24, 2019

    IV START KIT IV8440

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code LRS·April 24, 2019

    CVC BUNDLE, 20CM, 3L, PI ECVC5120

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019

    CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019