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

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    Elos® Intramedullary Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UP - Vehicle - 380-55230 - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306823848·Stainless Steel Breast Elevator w/ ratchet 29cm...

    MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ENHANCED POLYETHYLENE KNEE PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·November 20, 2001

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·January 16, 2003

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·January 3, 2019

    ASKU

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 14, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    CTM PINN CONSTR LINER 50X28

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 2, 2013

    AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    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