BEUDAMED
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    Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.

    FDA Recall
    Terminated ·European Custom Manufacturing B.V. Oost-Om 54 Gemert Netherlands·Product code LDF·April 18, 2011

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Enforcement
    Class II ·Terminated·Flexicare Medical Ltd.·January 22, 2020

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019

    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Enforcement
    Class II ·Terminated·Flexicare Medical Ltd.·January 22, 2020

    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code CCW·November 27, 2019

    AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MAE·September 6, 2005

    AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MAE·September 6, 2005

    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

    Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code MCB·December 26, 2002

    Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121

    FDA Recall
    Terminated ·Biosite Inc·Product code MCB·December 4, 2007

    Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code MCB·December 26, 2002

    AMPLATZER Duct Occluder, Order No. 9-PDA-007, Device Size 12/10mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MAE·September 6, 2005

    AMPLATZER Duct Occluder, Order No. 9-PDA-004, Device Size 6/4mm, Length 7 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MAE·September 6, 2005

    AMPLATZER Duct Occluder, Order No. 9-PDA-005, Device Size 8/6mm, Length 7 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MAE·September 6, 2005

    CMExpress Microbore Sets, REF: A120-160CYFRV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset, REF: A120-160XSFK

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    CMExpress Microbore Sets, REF: A120-161C

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset, REF: A120-161XPSV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    CMExpress Microbore Set, REF: A120-160CRV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020