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

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    CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Essential Kit

    FDA UDI
    MEDIVATORS INC.·40677964008649·Essential Kit includes Suction Tubing, Pentax V...

    ACCUTRANS™ Disposable Pressure Monitoring System

    FDA UDI
    BIOPTIMAL INTERNATIONAL PTE. LTD.·08886483503854·

    ELECSYS B-CROSSLAPS CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    0001222315-2026-000942

    FDA Adverse Event
    Injury ·STRAUMANN MANUFACTURING, INC.·Product code DZE·April 2, 2026

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 3, 2014

    APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QLT·January 29, 2022

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 18, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 12, 2014

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·May 7, 2022

    VELOCITY DELIVERY MICROCATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DQY·September 24, 2015

    NEURON MAX 088 DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DQY·September 24, 2015

    LANTERN DELIVERY MICROCATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·January 24, 2020

    C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·BIOMET SPINE - BROOMFIELD·Product code KWQ·November 12, 2015

    MAXAN ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·BIOMET SPINE - BROOMFIELD·Product code KWQ·November 12, 2015

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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