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

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    EDEN Peek Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446888291·Special, EMPOWR Partial Knee Distal Resection G...

    UNKNOWN SALINE IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·May 14, 2024

    EBV EA-D IGG ELISA KIT, MODEL EBG-100

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SYNTHES SCALLOPED DISTAL TIBIA PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·October 15, 2008

    PULSE GEN MODEL102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code MUZ·August 5, 2011

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·July 2, 2013

    OPTIFLOW FILTERED NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·November 29, 2021

    OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 16, 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

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·November 14, 2018

    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