BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C

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

    MDI GLIADIN G TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    TINA-QUANT COMPLEMENT C4 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEKA SMARTXIDE WITH DOT SCANNER

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 14, 2023

    ASR TAP SLV ADAP 12/14 -1

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·March 17, 2016

    1 X 5MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5 EA

    FDA Adverse Event
    Malfunction ·CONMED LARGO·Product code GFF·October 12, 2021

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 18, 2013

    COULTER LH 750 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LOQ·April 28, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022