BEUDAMED
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    OLSEN ELECTROSURGICAL INC.

    FDA Adverse Event
    Malfunction ·OEI·Product code GEI·August 23, 1999

    AVANCE CS2

    FDA Adverse Event
    Injury ·DATEX-OHMEDA, INC.·Product code BSZ·March 25, 2022

    AVANCE

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA INC·Product code BSZ·February 1, 2022

    ELUTIA WOUND DRAIN

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL INC.·Product code OEI·May 15, 2014

    BARD CHANNEL DRAIN, 19 FR. ROUND HUBLESS FULL FLUTED, SILICONE.

    FDA Adverse Event
    C.R. BARD, INC.·Product code OEI·November 3, 2017

    ELUTIA

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL INC.·Product code OEI·February 26, 2013

    MEDTRONIC VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROLOGICAL TECHNOLOGIES·Product code OEI·March 24, 2015

    EXPEL¿ MULTO-PURPOSE DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OEI·September 26, 2017

    XENMATRIX AB

    FDA Adverse Event
    Death ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code PIJ·April 3, 2025

    Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

    FDA Recall
    Open, Classified ·Abbott Laboratories, Inc·Product code MZA·February 3, 2022

    Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories, Inc·March 23, 2022

    Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.

    FDA Recall
    Terminated ·Bacterin International, Inc.·Product code OEI·January 28, 2013

    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.

    FDA Recall
    Terminated ·Bacterin International, Inc.·Product code OEI·May 15, 2014

    Drainage Catheter With Antibiotic

    FDA classification
    FDA Class 2 ·Drainage Catheter With Antibiotic

    Dei Italia Srl

    Manufacturer
    🇮🇹 Italy

    Arizona AFO

    Manufacturer
    🇺🇸 United States

    Apex Foot Health Industries, LLC

    Manufacturer
    🇺🇸 United States

    The Orthotic Group, Inc.

    Manufacturer
    🇨🇦 Canada

    Orthotic Holdings Inc.

    Manufacturer
    🇺🇸 United States

    Silca dei F.lli Beldì S.r.l.

    Manufacturer
    🇮🇹 Italy