BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827943·ACHIMED ACHILLES SUPP BLACK VI

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101236·Burs FGSL 4, Pkg/5

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450274392·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450273081·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450237915·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540756206·11MM CORTEX REAMER TIBIAL

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450412954·

    APPRAISE URINE MICROALBUMIN COLLECTION KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·June 15, 2016

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·March 25, 2013

    5.0MM TI LOCKING HEAD SCREW

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code KTT·March 7, 2011

    HUDSON AQUAPAK 601 SW,650 ML,JAPAN

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·January 11, 2016

    OLYMPUS CYSTOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code NWB·April 28, 2021

    Aurora Series, Aurora 7 lighthead; Models: LED7 (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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016