BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    ADAM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033978·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...

    SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007

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

    RAD-5V HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 10, 2015

    RAD-5 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

    SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 18, 2011

    PFC SIGMA/RD/DOME PAT 3PEG, 38

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 24, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·December 2, 2025

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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 Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024