BEUDAMED
    23 results · 27ms · Sources: EU EUDAMED, US FDA

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    VIPER SYSTEM, EXPEDIUM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691035·

    QUANTUM BLAST

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS·Product code LWS·May 8, 1997

    PORTEX

    FDA Adverse Event
    Malfunction ·CONCORD/PORTEX·Product code BTO·August 2, 1993

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 1, 2024

    DEPUY TRI-LOCK LOW PROFILE TOTAL HIP CUP

    FDA Adverse Event
    Malfunction ·DEPUY·Product code LPH·June 17, 1993

    UNKNOWN

    FDA Adverse Event
    UNKNOWN·July 1, 1993

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·June 13, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 3, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·September 19, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 18, 2011

    INVACARE INNOVATION IN HEALTH CARE

    FDA Adverse Event
    Death ·INVACARE INNOVATION IN HEALTH CARE·August 31, 1993

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    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

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021