BEUDAMED
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    CURE CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

    FDA Recall
    Terminated ·Cure Medical LLC·Product code EZD·September 19, 2012

    Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud¿-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

    FDA Enforcement
    Class II ·Terminated·Cure Medical LLC·October 10, 2012

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496072539·BE YOU STEP-UP CURVY, SIZE M-XL, BLU TONIC, OPA...

    OBC-096 BREAST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERASTEP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MATRIX DETACHABLE COILS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code HCG·October 12, 2010

    GDC DETACHABLE COIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION·Product code HCG·October 13, 2009

    GDC DETACHABLE COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·November 3, 2009

    GDC DETACHABLE COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·November 3, 2009

    GUGLIELMI DETACHABLE COIL (GDC)

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·November 2, 2009

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 8, 2024

    GDC DETACHABLE COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION BOSTON SCIENTIFIC CORP.·Product code HCG·September 17, 2009

    GDC DETACHABLE COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·September 17, 2009

    GDC DETACHABLE COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·September 17, 2009

    GDC DETACHABLE COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·September 17, 2009

    UNKNOWN VERSASTEP

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·June 11, 2015

    GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIV. BOSTON SCIENTIFIC CORP·Product code HCG·November 11, 2009

    GDC DETACHABLE COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·September 16, 2009

    GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code HCG·July 20, 2010