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

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    Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707184254·Accufit Molar Bands Lower Right Second Molar 29...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114186·KRATZ POLISHER 21GA SIDE (PK/10)

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133197·LATERAL,SILICONE HANDLE,DISCECTOMY

    IlluminOss Bone Stabilization System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUICKSCREEN COCAINE 150 SCREENING TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GOLDLINE DISPOSABLE PUSH BUTTON ELECTROSURGICAL PENCIL

    FDA Adverse Event
    Malfunction ·CONMED ELECTROSURGERY·Product code GEI·April 12, 2013

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code DRF·October 14, 2008

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021