BEUDAMED
    20 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    iPico Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    IELLIOS Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code DYB·May 8, 2006

    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    FDA Recall
    Terminated ·EEG Info·Product code HCC·November 15, 2012

    V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538

    FDA Recall
    Terminated ·Neo Medical, Inc.·Product code LRS·April 5, 2011

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    FDA Recall
    Terminated ·NEO METRICS, INC.·Product code OCY·March 31, 2014

    Plicator EPS Plication System Catalog Number: 160-01128R

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

    Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

    FDA Recall
    Terminated ·Helena Laboratories, Corp.·Product code GFO·January 5, 2021

    Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Recall
    Terminated ·Helena Laboratories, Corp.·Product code GFO·December 7, 2017

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code GFO·December 19, 2013

    TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Abeon Medical Corporation·Product code FFO·November 25, 2015

    TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.

    FDA Recall
    Terminated ·Abeon Medical Corporation·Product code FFO·November 25, 2015

    Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GFO·July 18, 2006

    Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GFO·November 14, 2018

    Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GFO·November 14, 2018

    Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GFO·March 25, 2015

    Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code GFO·March 1, 2004

    Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.

    FDA Recall
    Terminated ·Normand-Info S.A.S.U. 7 rue Frederic Degeorge Arras CEDEX France·Product code JQP·April 30, 2020

    Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems

    FDA Recall
    Terminated ·Normand-Info S.A.S.U. 7 rue Frederic Degeorge Arras CEDEX France·Product code JQP·August 15, 2019

    Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

    FDA Recall
    Terminated ·Normand-Info S.A.S.U. 7 rue Frederic Degeorge Arras CEDEX France·Product code JQP·March 22, 2021