BEUDAMED
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    ANTISERUM TO HUMAN KAPPA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    X-View 3D Pan/X-View 2D Pan

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·November 27, 2007

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 7, 2012

    bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 6, 2013

    PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LXG·August 28, 2012

    MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code OOI·May 10, 2011

    SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media.

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JWX·December 21, 2011

    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·June 10, 2024

    Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code NJR·November 23, 2015

    BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·June 10, 2024