BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4

    FDA 510(k)
    FDA Class 2 ·Dental

    VIvid NanoFil Refill Syringe D-4

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724D0101320·

    ZEUS-O

    FDA UDI
    SPINAL ELEMENTS·00840916157159·ZEUS®-O TRIAL HEAD CADDY, 32MM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450046470·

    DIAGNOSTICS BIOCHEM CANADA, INC.

    FDA registration
    DIAGNOSTICS BIOCHEM CANADA, INC.·16 products·🇨🇦 Canada

    Intess L

    FDA UDI
    Kalitec Direct LLC·B07312K0100320·Assembly, Caddie, 30mm Lumbar Implants, Hinged

    ADVIA CENTAUR XP TNI-ULTRA ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 8, 2018

    Lumbar Plate System

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLP10101320·32mm Lumbar Plate Drill

    BONE BIOPSY NEEDLE

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

    ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8

    FDA 510(k)
    FDA Class 2 ·Immunology

    2520274-2013-01589

    FDA Adverse Event
    Injury ·SYNTHES (USA) WEST CHESTER, PA·Product code MCV·March 19, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 1, 2011

    ON-Q PAINBUSTER

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code MEB·March 7, 2008

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013