BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    OTOSCREENER-I AND OTO-SCREEN-I-P

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Family Wellness

    FDA UDI
    Family Dollar Stores·00032251057625·Sheer Adhesive Pad, all one size, 3 IN x 4 IN (...

    MISSION BREATH ALCOHOL DETECTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MILLENNIUM BLADES, MODEL MB101

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BD SYRINGE S2 5ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·September 9, 2019

    METRX II

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·October 27, 2025

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016

    TPS HANDPIECE CORD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·June 30, 2014

    ASR ACETABULAR IMPLANT 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·November 17, 2010

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODUALTION·Product code LGW·January 2, 2013

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024