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

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    LineSider™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORION PLATINUM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DETECTAR, MODEL N123-MI

    FDA 510(k)
    FDA Class 1 ·Dental

    RIO ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DXE·October 15, 2008

    CONSULTA CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    OBTRYX SYSTEM

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

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·November 17, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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