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

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    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HRS·September 3, 2021

    Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    FDA Enforcement
    Class III ·Terminated·Bion Enterprises Ltd·June 12, 2013

    Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    FDA Enforcement
    Class III ·Terminated·Bion Enterprises Ltd·June 12, 2013

    UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DQO·November 5, 2003

    Endotine Transbleph 3.5 (CFD-080-0167)

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·August 3, 2016

    Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Recall
    Terminated ·Ceg Enterprises Llc·Product code MCF·April 5, 2016

    GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010

    Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005

    Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005

    Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNL·January 1, 2006

    IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFL·August 9, 2010

    VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CFJ·June 12, 2013

    Advia Chemistry Assay: Lactate

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·March 17, 2016