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

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    LinkSymphoKnee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694049566·Screw Organizer Block

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694052597·Screw Gauge Insert, Screw Module

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694052610·Option Insert, Instrument Holder, 3.5

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694055086·Screw Gauge Insert, Additional Length, Solid Sc...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694052627·Option Insert, Instrument Holder, 4.0

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694052603·Option Insert, Instrument Holder, 3.5/4.0

    3D ENDOSCOPE

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

    SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·October 17, 2008

    SPECTRAFLEX

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

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 2, 2013

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018

    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 L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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