BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.

    FDA Recall
    Terminated ·Ossur Grjothals 5 Reykjavik Ireland·Product code ISH·October 21, 2005

    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code NJT·May 6, 2015

    ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CEM·July 10, 2019

    O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OWB·November 15, 2019

    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

    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

    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    FDA Recall
    Terminated ·Alivecor SFO·Product code DXH·January 9, 2015

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code ODG·May 23, 2017

    Pentax Video Colonoscope Model: EC34-i10L

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDF·January 3, 2020

    Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDF·August 15, 2016

    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.

    FDA Recall
    Terminated ·PENTAX of America Inc·Product code GEH·March 30, 2018