BEUDAMED
    30 results · 11ms · Sources: EU EUDAMED, US FDA

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    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

    FDA Enforcement
    Class II ·Terminated·Bien Air Dental SA·September 30, 2015

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code OSI·March 18, 2014

    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code OSI·March 18, 2014

    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code FNM·March 18, 2014

    Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.

    FDA Recall
    Terminated ·Apheresis Technologies, Inc.·Product code FIR·July 9, 2012

    Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    FDA Recall
    Terminated ·Apheresis Technologies, Inc.·Product code FIR·April 1, 2009

    American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic

    FDA Recall
    Terminated ·American Diagnostica, Inc.·Product code GIR·February 28, 2007

    PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    FDA Recall
    Terminated ·Apheresis Technologies, Inc.·Product code FIR·November 29, 2010

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

    FDA Recall
    Terminated ·Extended Care Air Therapy Systems Inc·Product code FNL·April 5, 2006

    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

    FDA Recall
    Terminated ·Bien Air Dental SA Langgasse 60 Biel/bienne Switzerland·Product code EGS·August 27, 2015

    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JSS·May 21, 2014

    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JSI·March 28, 2016

    BD AffirM VPIII Microbial Identification Test

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code MLA·August 27, 2015

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code MNM·September 21, 2018

    BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code PQA·September 24, 2018

    BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code PQA·September 24, 2018

    PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code LON·June 1, 2016