BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    PROSTATE-63 CANCER DIAGNOSTIC TEST

    FDA 510(k)
    FDA Class 1 ·Hematology

    APOLLO

    FDA UDI
    Conmed Corporation·20653405051722·APOLLO Papillotome, Double Lumen, 8mm Beveled T...

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496050063·RED WELLNESS 70 LEGGINGS, SIZE L, MOKA, GRADUAT...

    MedGyn Pessary Cube w/o drain # 8

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050063·Cube Pessary is used treat uterine prolapse.

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450363362·

    BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 19, 2021

    INSPEKTOR PRO

    FDA 510(k)
    FDA Class 2 ·Dental

    COUCH FOR TOTAL BODY RADIATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    LNOP MP12 PATIENT CABLE

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·May 15, 2015

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 10, 2013

    CROSSFIRE FOOTSWITCH

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·April 4, 2011

    SELECT SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·May 22, 2008

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018